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Senior Regulatory Affairs Specialist (Poland) at Indero
Warsaw, Masovian Voivodeship, Poland - Full Time
Skills Needed
Regulatory Affairs, Clinical Trials, Project Management, Regulatory Submissions, Irb/Iec Packages, Global Regulatory Requirements, Attention To Detail, Good Clinical Practices, Team Leadership, Mentoring, Process Improvement, Training, Communication Skills, Multitasking, Time Management, Technical Expertise
Specialization
Candidates should have a bachelor's degree in a scientific discipline and 3-5 years of experience in clinical regulatory affairs. A strong understanding of global regulatory requirements and fluency in English are also required.
Experience Required
Minimum 2 year(s)
Fine Dining Busser-536007 at Coushatta Casino Resort
Kinder, Louisiana, United States - Full Time
Skills Needed
Organizational Skills, Interpersonal Skills, Guest Services, Fine Dining, Table Cleaning, Table Resetting, Service Staff Collaboration
Specialization
A high school diploma or general education degree is preferred. Strong organizational and interpersonal skills are required.
Registered Nurse at Anovaworks, PLLC.
Pasco, Washington, United States - Full Time
Skills Needed
Critical Thinking, Acute Diagnostic Abilities, Occupational Health Nursing, Emergency Department Experience, Patient Care, Health Assessments, Safety Promotion, Nursing Interventions, Triage, Physical Examinations, Health Surveillance Testing, Venipuncture, Blood Specimen Collection, Health Promotion Strategies
Specialization
A qualified RN should have at least 2 years of nursing experience, preferably in occupational health or emergency settings. Current Washington state nursing licensure and basic life support certification are also required.
Experience Required
Minimum 2 year(s)
BPS Specialist at Bosch Group
Lincolnton, North Carolina, United States - Full Time
Skills Needed
Standardized Work, 5s, Pull Principle, Leveling, Problem Solving, Continuous Improvement Cycles, Total Productive Maintenance, Logistics Standardization, Quality Principles, Lean Mindset, Excel, Powerpoint, Power Bi, Value Stream Processes, Analytical, Coaching
Specialization
Candidates should have at least 5 years of experience in a manufacturing environment and 3 years of experience with Lean tools coaching and implementation. A strong understanding of continuous improvement methodologies and the ability to work cross-functionally is essential.
Experience Required
Minimum 5 year(s)
Freelance Technical Designer at BCI Brands
New York, New York, United States - Full Time
Skills Needed
Technical Design, Pattern Making, Draping, Garment Construction, Grading, Factory Production, Tech Packages, Communication, Attention To Detail, Multitasking, Self Motivation, Team Collaboration, Fit Analysis, Production Deadlines, Excel, Microsoft Office
Specialization
A bachelor's degree in Fashion Design or a related field is required, along with 4-6 years of experience in the apparel industry. Candidates should have knowledge of garment construction and be proficient in relevant software.
Experience Required
Minimum 5 year(s)
Principal Software Engineer - Backend at DigiCert Inc
Bengaluru, karnataka, India - Full Time
Skills Needed
Java, Spring, Spring Boot, Jpa, Restful Web Services, Mysql, Mariadb, Nosql, Aws, Azure, Cloud Native Applications, Kubernetes, Docker, Devops, Ci/Cd, Agile
Specialization
Bachelor’s degree in Computer Science or equivalent professional experience is required. Candidates should have 5+ years of experience in backend software development and strong proficiency in Java.
Experience Required
Minimum 5 year(s)
Freelance Surveyor Purwokerto at StickEarn
Purwokerto, Central Java, Indonesia - Full Time
Skills Needed
Research, Documentation, Spreadsheet, Google Maps, Communication, Creativity, Decision Making, Customer Service
Specialization
Candidates from all majors are welcome, preferably those in their final year of study. Familiarity with spreadsheets and Google Maps is essential, along with strong communication skills and a customer service orientation.
Renal Specialist I - Hemodialysis - FT - 1st Shift at Huntsville Hospital Health System
Huntsville, Alabama, United States - Full Time
Skills Needed
Patient Assessment, Care Planning, Delegation, Patient Evaluation, Icu Experience, Dialysis Experience, Documentation, Team Collaboration, Communication, Critical Thinking, Time Management, Patient Care, Health Monitoring, Problem Solving, Adaptability, Compassion
Specialization
Candidates must be graduates of an accredited school of nursing and hold a current Alabama or multistate nursing license. ICU and/or previous dialysis experience is preferred.
Manufacturing Process Technician VI at CATERPILLAR ASIA PTE LTD
, , China - Full Time
Skills Needed
Robotics, Automation, Mechatronics, Programming, Troubleshooting, Debugging, Fanuc, Ur, Abb, Plc, Hmi, Servo, Agv, Process Improvement, Technical Expertise, Mechanical, Electrical
Specialization
A bachelor's degree in a relevant field and at least 1 year of related experience are required. Strong technical aptitude with a focus on robotics and automation is essential.
2481M Day Support Professional at BAMSI Inc
, , Morocco - Full Time
Skills Needed
Personal Care, Activities Of Daily Living, Positive Behavior Supports, Nutritional Needs, Communication Tools, Community Based Activities, Financial Skills, Individual Support Plans, Documentation, Behavioral Support Plans, Emergency Interventions, Data Recording, Mobility Assistance, Safety Skills, Team Collaboration, Adaptability
Specialization
Candidates should have at least one year of experience working with individuals with disabilities and a high school diploma or equivalent. Experience with behavioral support plans and the ability to communicate effectively are also required.
Experience Required
Minimum 2 year(s)
Team Member at West Coast Convenience Stores Loop Neighborhood Market
Sacramento, California, United States - Full Time
Skills Needed
Customer Service, Cash Management, Product Stocking, Communication, Problem Solving, Sales, Teamwork, Flexibility
Specialization
Candidates must be able to work a flexible schedule and communicate effectively in English. They should also be able to perform basic math, lift up to 50 pounds, and tolerate exposure to gasoline fumes.
LPN Homecare at Maximum Health Care Solutions
Eau Claire, Wisconsin, United States - Full Time
Skills Needed
Licensed Practical Nurse, Patient Care, Nursing Process, Assessment, Data Analysis, Documentation, Bls Certification, Tb Test, Chest X Ray
Specialization
Currently licensed as an LPN/LVN in the state of practice and possess a current TB or Chest X-Ray and BLS card. One year of prior professional nursing experience is preferred.
Dependiente (H/M/D) Pamplona at ILUNION
, Navarre, Spain - Full Time
Skills Needed
Customer Service, Sales, Teamwork, Communication, Problem Solving, Inventory Management, Cash Handling, Store Maintenance
Specialization
Candidates should have a positive attitude and a willingness to learn. Teamwork and communication skills are essential for this position.
Memory Care Manager (LPN Required) at Grand Villa of Altamonte Springs
Altamonte Springs, Florida, United States - Full Time
Skills Needed
Nursing, Supervisory Skills, Communication, Problem Solving, Integrity, Judgment, Decision Making, Relationship Building, Training, Counseling, Risk Management, Health Care, Service Planning, Emergency Response, Personal Care, Compassion
Specialization
Candidates must have a nursing degree (LPN) and at least one year of supervisory experience. They should possess knowledge of facility licensure and OSHA regulations, along with excellent communication and problem-solving skills.
Experience Required
Minimum 2 year(s)
Toys"R"Us Sales Associate (Flagship Store) at Go! Retail Group
Wichita, Kansas, United States - Full Time
Skills Needed
Customer Service, Sales, Communication, Retail Operations, Merchandising, Inventory Control, Point Of Sale, Problem Solving, Attention To Detail, Teamwork, Self Motivation, Integrity, Reliability, Enthusiasm, Basic Math Skills, Computer Skills
Specialization
No retail experience is necessary, but at least 3 months of retail experience is a plus. Candidates should possess excellent verbal communication skills and a friendly, professional demeanor.
IT Operations Technician at Lagoon Amusement Park
Farmington, Utah, United States - Full Time
Skills Needed
Technical Support, Troubleshooting, Networking, Active Directory, Cloud Environments, Cybersecurity, Documentation, Collaboration, Communication, Windows, Macos, Virtualization, Scripting, Itil, Ticketing Systems, Problem Solving
Specialization
Candidates must have an associate’s degree in a related field or equivalent experience, along with a minimum of two years in IT support. Proficiency in Windows and macOS, networking fundamentals, and strong troubleshooting skills are essential.
Experience Required
Minimum 2 year(s)
Conseiller commercial H/F at Will RH
Madrid, Community of Madrid, Spain - Full Time
Skills Needed
Sales, Customer Service, Communication, Crm Management, Problem Solving
Specialization
No specific experience is required, making it suitable for entry-level candidates. Candidates should be motivated and capable of transforming calls into successful sales.
Principal Product Marketing Manager at Elastic
, , United States - Full Time
Skills Needed
Product Marketing, Technical Products, Content Creation, Cross Functional Collaboration, Technical Messaging, Developer Engagement, Product Launches, Training, Storytelling, Saas, Infrastructure Products, Writing Skills, Public Speaking, Partnership Building, Market Penetration, Campaign Support
Specialization
Candidates should have 5-10 years of experience in product marketing for technical products and a proven track record of effectively marketing to developers. Strong writing skills and the ability to engage with technical audiences are essential.
Experience Required
Minimum 5 year(s)
Tech East General Application at BELFOR Franchise Group
City of Schenectady, New York, United States - Full Time
Skills Needed
Customer Focus, Commitment, Dedication, Integrity, Work Ethic
Specialization
Candidates should strive to do their best and ensure customer interests are prioritized. A strong commitment to integrity and work ethic is essential.
Manager Soft Controls Auditor at KPMG Nederland
Amstelveen, North Holland, Netherlands - Full Time
Skills Needed
Soft Controls, Internal Audits, Organizational Culture, Behavior Analysis, Project Management, Team Leadership, Client Engagement, Coaching, Financial Audits, Observation Techniques, Interview Techniques, Survey Techniques, Cultural Awareness, Dutch Language Proficiency, English Language Proficiency
Specialization
A master's degree in a relevant field such as economics, business administration, or accountancy is required, along with at least 5 years of experience in internal audits focusing on behavior and culture. Candidates should have knowledge in the soft controls domain and a strong affinity for culture, behavior, and auditing.
Experience Required
Minimum 5 year(s)
Senior Regulatory Affairs Specialist (Poland) at Indero
Warsaw, Masovian Voivodeship, Poland -
Full Time

Start Date

Immediate

Expiry Date

07 Mar, 26

Salary

0.0

Posted On

07 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Affairs, Clinical Trials, Project Management, Regulatory Submissions, IRB/IEC Packages, Global Regulatory Requirements, Attention To Detail, Good Clinical Practices, Team Leadership, Mentoring, Process Improvement, Training, Communication Skills, Multitasking, Time Management, Technical Expertise

Industry

Research Services

Description
The Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions. This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables within a country, region or globally. This role will also support the Associate Director Regulatory Affairs in special projects, process improvement initiatives, training of new employees and company initiatives. RESPONSABILITIES Coordinates regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions. Lead global/multinational submissions of complex large clinical trials. Addresses Sponsor queries related to regulatory and submission requirements. Provides regulatory support and advice to project teams; provides project-specific local submission strategy and technical expertise. Prepares/reviews core packages and country packages for submission to RA (initial applications, amendment packages, and notifications) in assigned countries to ensure compliance. Peer review of documents and packages prepared by colleagues within regulatory team. Develops/reviews Country ICFs. Performs regulatory review of essential documents and authorizes regulatory release prior to the shipment of investigational product to clinical sites. Develops/reviews country-specific labelling content for clinical trial drug supplies to ensure conformity with regional regulations requirements. Participates in Kick-off meetings, client audits, and other project related meetings according to the company / client needs Act as a mentor to new or junior colleagues within regulatory team. Responsibilities could include helping in assigning work; coaching/training; providing instructions; developing tools and processes to help daily work; helping in maintaining high quality of work of regulatory/ethics submissions Support Regulatory Country Intelligence activities Requirements Bachelors' degree (or equivalent) in a scientific discipline. Regulatory Affairs is an asset 3-5 years in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry; experience preparing and submitting IRB/IEC packages and /or Clinical Trial Applications Strong understanding of global regulatory requirements and guidelines in assigned countries / regions. Experience in global leadership role with a focus on regulatory regions such as Europe and APAC (Australia/New Zealand). Experience of the regulatory process under EU-CTR. Fluency in English with excellent oral and written skills, required Additional languages represent an asset Attention to detail and accuracy in work Ability to organize own work, prioritize different assignments, and work under pressure Versatile and comfortable in a multitasking environment Respect established timelines, expectations, priorities, and objectives Good knowledge of good clinical practices, applicable Health Canada and Food and Drug Administration (FDA), and Regulation (EU) No 536/2014. Our company The work environment At Indero, you will work with brilliant and driven colleagues. Our values are integrity, commitment and teamwork. We offer a stimulating work environment and attractive advancement opportunities. As a Senior Regulatory Affairs Specialist, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities) Ongoing learning and development About Indero Indero is a contract research organization (CRO) specialized in dermatology and Rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Poland. Description - Fr null Profil recherché null Notre entreprise null
Responsibilities
The Senior Regulatory Affairs Specialist will lead regulatory activities for clinical trial startups and oversee complex multinational submissions. This role includes providing regulatory support to project teams and mentoring junior colleagues.
Senior Regulatory Affairs Specialist (Poland) at Indero
Warsaw, Masovian Voivodeship, Poland - Full Time
Skills Needed
Regulatory Affairs, Clinical Trials, Project Management, Regulatory Submissions, Irb/Iec Packages, Global Regulatory Requirements, Attention To Detail, Good Clinical Practices, Team Leadership, Mentoring, Process Improvement, Training, Communication Skills, Multitasking, Time Management, Technical Expertise
Specialization
Candidates should have a bachelor's degree in a scientific discipline and 3-5 years of experience in clinical regulatory affairs. A strong understanding of global regulatory requirements and fluency in English are also required.
Experience Required
Minimum 2 year(s)
Fine Dining Busser-536007 at Coushatta Casino Resort
Kinder, Louisiana, United States - Full Time
Skills Needed
Organizational Skills, Interpersonal Skills, Guest Services, Fine Dining, Table Cleaning, Table Resetting, Service Staff Collaboration
Specialization
A high school diploma or general education degree is preferred. Strong organizational and interpersonal skills are required.
Registered Nurse at Anovaworks, PLLC.
Pasco, Washington, United States - Full Time
Skills Needed
Critical Thinking, Acute Diagnostic Abilities, Occupational Health Nursing, Emergency Department Experience, Patient Care, Health Assessments, Safety Promotion, Nursing Interventions, Triage, Physical Examinations, Health Surveillance Testing, Venipuncture, Blood Specimen Collection, Health Promotion Strategies
Specialization
A qualified RN should have at least 2 years of nursing experience, preferably in occupational health or emergency settings. Current Washington state nursing licensure and basic life support certification are also required.
Experience Required
Minimum 2 year(s)
BPS Specialist at Bosch Group
Lincolnton, North Carolina, United States - Full Time
Skills Needed
Standardized Work, 5s, Pull Principle, Leveling, Problem Solving, Continuous Improvement Cycles, Total Productive Maintenance, Logistics Standardization, Quality Principles, Lean Mindset, Excel, Powerpoint, Power Bi, Value Stream Processes, Analytical, Coaching
Specialization
Candidates should have at least 5 years of experience in a manufacturing environment and 3 years of experience with Lean tools coaching and implementation. A strong understanding of continuous improvement methodologies and the ability to work cross-functionally is essential.
Experience Required
Minimum 5 year(s)
Freelance Technical Designer at BCI Brands
New York, New York, United States - Full Time
Skills Needed
Technical Design, Pattern Making, Draping, Garment Construction, Grading, Factory Production, Tech Packages, Communication, Attention To Detail, Multitasking, Self Motivation, Team Collaboration, Fit Analysis, Production Deadlines, Excel, Microsoft Office
Specialization
A bachelor's degree in Fashion Design or a related field is required, along with 4-6 years of experience in the apparel industry. Candidates should have knowledge of garment construction and be proficient in relevant software.
Experience Required
Minimum 5 year(s)
Principal Software Engineer - Backend at DigiCert Inc
Bengaluru, karnataka, India - Full Time
Skills Needed
Java, Spring, Spring Boot, Jpa, Restful Web Services, Mysql, Mariadb, Nosql, Aws, Azure, Cloud Native Applications, Kubernetes, Docker, Devops, Ci/Cd, Agile
Specialization
Bachelor’s degree in Computer Science or equivalent professional experience is required. Candidates should have 5+ years of experience in backend software development and strong proficiency in Java.
Experience Required
Minimum 5 year(s)
Freelance Surveyor Purwokerto at StickEarn
Purwokerto, Central Java, Indonesia - Full Time
Skills Needed
Research, Documentation, Spreadsheet, Google Maps, Communication, Creativity, Decision Making, Customer Service
Specialization
Candidates from all majors are welcome, preferably those in their final year of study. Familiarity with spreadsheets and Google Maps is essential, along with strong communication skills and a customer service orientation.
Renal Specialist I - Hemodialysis - FT - 1st Shift at Huntsville Hospital Health System
Huntsville, Alabama, United States - Full Time
Skills Needed
Patient Assessment, Care Planning, Delegation, Patient Evaluation, Icu Experience, Dialysis Experience, Documentation, Team Collaboration, Communication, Critical Thinking, Time Management, Patient Care, Health Monitoring, Problem Solving, Adaptability, Compassion
Specialization
Candidates must be graduates of an accredited school of nursing and hold a current Alabama or multistate nursing license. ICU and/or previous dialysis experience is preferred.
Manufacturing Process Technician VI at CATERPILLAR ASIA PTE LTD
, , China - Full Time
Skills Needed
Robotics, Automation, Mechatronics, Programming, Troubleshooting, Debugging, Fanuc, Ur, Abb, Plc, Hmi, Servo, Agv, Process Improvement, Technical Expertise, Mechanical, Electrical
Specialization
A bachelor's degree in a relevant field and at least 1 year of related experience are required. Strong technical aptitude with a focus on robotics and automation is essential.
2481M Day Support Professional at BAMSI Inc
, , Morocco - Full Time
Skills Needed
Personal Care, Activities Of Daily Living, Positive Behavior Supports, Nutritional Needs, Communication Tools, Community Based Activities, Financial Skills, Individual Support Plans, Documentation, Behavioral Support Plans, Emergency Interventions, Data Recording, Mobility Assistance, Safety Skills, Team Collaboration, Adaptability
Specialization
Candidates should have at least one year of experience working with individuals with disabilities and a high school diploma or equivalent. Experience with behavioral support plans and the ability to communicate effectively are also required.
Experience Required
Minimum 2 year(s)
Team Member at West Coast Convenience Stores Loop Neighborhood Market
Sacramento, California, United States - Full Time
Skills Needed
Customer Service, Cash Management, Product Stocking, Communication, Problem Solving, Sales, Teamwork, Flexibility
Specialization
Candidates must be able to work a flexible schedule and communicate effectively in English. They should also be able to perform basic math, lift up to 50 pounds, and tolerate exposure to gasoline fumes.
LPN Homecare at Maximum Health Care Solutions
Eau Claire, Wisconsin, United States - Full Time
Skills Needed
Licensed Practical Nurse, Patient Care, Nursing Process, Assessment, Data Analysis, Documentation, Bls Certification, Tb Test, Chest X Ray
Specialization
Currently licensed as an LPN/LVN in the state of practice and possess a current TB or Chest X-Ray and BLS card. One year of prior professional nursing experience is preferred.
Dependiente (H/M/D) Pamplona at ILUNION
, Navarre, Spain - Full Time
Skills Needed
Customer Service, Sales, Teamwork, Communication, Problem Solving, Inventory Management, Cash Handling, Store Maintenance
Specialization
Candidates should have a positive attitude and a willingness to learn. Teamwork and communication skills are essential for this position.
Memory Care Manager (LPN Required) at Grand Villa of Altamonte Springs
Altamonte Springs, Florida, United States - Full Time
Skills Needed
Nursing, Supervisory Skills, Communication, Problem Solving, Integrity, Judgment, Decision Making, Relationship Building, Training, Counseling, Risk Management, Health Care, Service Planning, Emergency Response, Personal Care, Compassion
Specialization
Candidates must have a nursing degree (LPN) and at least one year of supervisory experience. They should possess knowledge of facility licensure and OSHA regulations, along with excellent communication and problem-solving skills.
Experience Required
Minimum 2 year(s)
Toys"R"Us Sales Associate (Flagship Store) at Go! Retail Group
Wichita, Kansas, United States - Full Time
Skills Needed
Customer Service, Sales, Communication, Retail Operations, Merchandising, Inventory Control, Point Of Sale, Problem Solving, Attention To Detail, Teamwork, Self Motivation, Integrity, Reliability, Enthusiasm, Basic Math Skills, Computer Skills
Specialization
No retail experience is necessary, but at least 3 months of retail experience is a plus. Candidates should possess excellent verbal communication skills and a friendly, professional demeanor.
IT Operations Technician at Lagoon Amusement Park
Farmington, Utah, United States - Full Time
Skills Needed
Technical Support, Troubleshooting, Networking, Active Directory, Cloud Environments, Cybersecurity, Documentation, Collaboration, Communication, Windows, Macos, Virtualization, Scripting, Itil, Ticketing Systems, Problem Solving
Specialization
Candidates must have an associate’s degree in a related field or equivalent experience, along with a minimum of two years in IT support. Proficiency in Windows and macOS, networking fundamentals, and strong troubleshooting skills are essential.
Experience Required
Minimum 2 year(s)
Conseiller commercial H/F at Will RH
Madrid, Community of Madrid, Spain - Full Time
Skills Needed
Sales, Customer Service, Communication, Crm Management, Problem Solving
Specialization
No specific experience is required, making it suitable for entry-level candidates. Candidates should be motivated and capable of transforming calls into successful sales.
Principal Product Marketing Manager at Elastic
, , United States - Full Time
Skills Needed
Product Marketing, Technical Products, Content Creation, Cross Functional Collaboration, Technical Messaging, Developer Engagement, Product Launches, Training, Storytelling, Saas, Infrastructure Products, Writing Skills, Public Speaking, Partnership Building, Market Penetration, Campaign Support
Specialization
Candidates should have 5-10 years of experience in product marketing for technical products and a proven track record of effectively marketing to developers. Strong writing skills and the ability to engage with technical audiences are essential.
Experience Required
Minimum 5 year(s)
Tech East General Application at BELFOR Franchise Group
City of Schenectady, New York, United States - Full Time
Skills Needed
Customer Focus, Commitment, Dedication, Integrity, Work Ethic
Specialization
Candidates should strive to do their best and ensure customer interests are prioritized. A strong commitment to integrity and work ethic is essential.
Manager Soft Controls Auditor at KPMG Nederland
Amstelveen, North Holland, Netherlands - Full Time
Skills Needed
Soft Controls, Internal Audits, Organizational Culture, Behavior Analysis, Project Management, Team Leadership, Client Engagement, Coaching, Financial Audits, Observation Techniques, Interview Techniques, Survey Techniques, Cultural Awareness, Dutch Language Proficiency, English Language Proficiency
Specialization
A master's degree in a relevant field such as economics, business administration, or accountancy is required, along with at least 5 years of experience in internal audits focusing on behavior and culture. Candidates should have knowledge in the soft controls domain and a strong affinity for culture, behavior, and auditing.
Experience Required
Minimum 5 year(s)