Senior Manager, CMC Regulatory Affairs at Moderna

Norwood, Massachusetts, United States - Full Time

Skills Needed
Cmc Regulatory Affairs, Regulatory Strategy, Ind/Cta/Bla/Maa Submissions, Ctd Format, Cgmp, Biologics, Health Authority Interaction, Change Control Evaluation, Regulatory Compliance, Technical Writing, Project Management, Analytical Development

Specialization
Requires over 10 years of pharmaceutical/biotech experience with at least 5 years focused on Regulatory CMC, preferably in biologics. A postgraduate degree in Pharmaceutics, Chemistry, or Chemical Engineering is desired.

Experience Required
Minimum 10 year(s)

Caregiver Needed in University Park, IL – Bring Comfort, Companionship, and at RES Consultant Group

University Park, Illinois, United States - Full Time

Skills Needed
Medication Reminders, Ambulation Assistance, Personal Care, Hygiene Care, Physical Therapy Assistance, Light Housekeeping, Meal Preparation, Emergency Response, Time Management, Interpersonal Skills, Communication

Specialization
Candidates must have at least one year of home care experience, a valid driver's license, and a high school diploma. Strong interpersonal skills, reliability, and the physical endurance to perform caregiving tasks are required.

Pediatric Acute Physical Therapist I-Dallas Medical Center at Children's Health StarCenters

Dallas, Texas, United States - Full Time

Skills Needed
Physical Therapy Evaluation, Pediatric Care, Acute Care, Treatment Planning, Interdisciplinary Collaboration, Patient Documentation, Discharge Planning, Patient Re Evaluation

Specialization
Requires a professional degree in physical therapy and a valid license to practice in the State of Texas. BLS certification from the American Heart Association is required, with pediatric acute care experience preferred.

Behavioral Health Therapist- Anderson at Community Health Network

Anderson, Indiana, United States - Full Time

Skills Needed
Case Management, Individual Therapy, Family Therapy, Group Therapy, Crisis Intervention, Treatment Planning, Psychosocial Assessments, Collaborative Teamwork, Communication Skills, Problem Solving, Discharge Planning, Psychological First Aid

Specialization
Candidates must hold a Master's degree in a mental health field and be licensed as an LCSW, LMHC, or LMFT in Indiana. A minimum of 2 years of experience in mental health treatment and a valid Indiana driver's license are required.

Experience Required
Minimum 2 year(s)

Substance Abuse Counselor I at MTC

Huntsville, Texas, United States - Full Time

Skills Needed
Substance Abuse Counseling, Recovery Skills Training, Clinical Interviewing, Case Management, Treatment Planning, Offender Evaluation, Crisis Intervention, Therapeutic Community Management, Reporting And Documentation, Aftercare Planning

Specialization
Requires a high school diploma and current registration as a Counselor Intern (LCDC-I) or CCJP-A certification. Candidates must possess a valid Texas driver's license and be able to complete Correctional Awareness Training.

Veterinary Assistant at Independence Veterinary Clinic

Charlotte, North Carolina, United States - Full Time

Skills Needed
Animal Handling, Animal Restraint, Surgical Assistance, Laboratory Testing, Medication Administration, Vaccination Administration, Medical Record Maintenance, Client Communication, Sterilization, Disinfection, Diagnostic Equipment Operation

Specialization
Requires previous experience in a veterinary setting and technical proficiency in administering medication and using diagnostic equipment. Must have the physical ability to handle animals compassionately and safely.

Experience Required
Minimum 2 year(s)

OB/GYN Gynecologist - Panorama City at Southern California Permanente Medical Group

Santa Clarita, California, United States - Full Time

Skills Needed
Gynecology, Obstetrics, Patient Care, Clinical Leadership, Medical Diagnosis, Treatment Planning

Specialization
Candidates must be Board Certified or Board Eligible in OB/GYN. Must pass a background check and drug screen.

Experience Required
Minimum 5 year(s)

General Superintendent – Miscellaneous Metals at Qualdoc

, Virginia, United States - Full Time

Skills Needed
Field Operations Leadership, Miscellaneous Metals Installation, Safety Compliance, Labor Scheduling, Resource Coordination, Aws D1.1, Welding Processes, Bluebeam, Trimble Connect, Tekla, Rigging, Project Execution

Specialization
Requires over 10 years of experience in miscellaneous metals installation and strong leadership skills. Proficiency in AWS D1.1 welding processes and tools like Bluebeam and Tekla is expected, along with a valid driver's license.

Experience Required
Minimum 10 year(s)

Senior Director, Global Order to Cash at Versant

Englewood Cliffs, New Jersey, United States - Full Time

Skills Needed
Order To Cash, Billing, Collections, Credit Management, Customer Master Data, Cash Application, Accounts Receivable, Sap, Salesforce, Financial Control, Regulatory Compliance, Performance Metrics, Process Improvement, Stakeholder Management, Operational Excellence, Team Leadership

Specialization
A bachelor's degree in Accounting, Finance, Business, or a related field is required, along with 10+ years of experience in leading Order to Cash functions. Candidates should have deep knowledge of billing, collections, and cash application operations in complex, global organizations.

Experience Required
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Manager, NAV Oversight at IQ-EQ

Hyderabad, Telangana, India - Full Time

Skills Needed
Fund Accounting, People Management, Regulatory Compliance, Risk Management, Resource Allocation, Capacity Planning, Client Relationship Management, Process Optimization, Change Management, Financial Reporting, Performance Metrics, Operational Excellence

Specialization
Requires a Bachelor's degree in Accounting, Finance, or Business Administration, with a CPA or equivalent certification preferred. Candidates need 7-14 years of experience in the financial industry, specifically within Private Equity, Hedge Funds, or Fund Accounting.

Experience Required
Minimum 10 year(s)

Technical Project Manager at Searidge Technologies

, , - Full Time

Skills Needed
Project Management, Waterfall Methodology, Agile Methodology, Stakeholder Management, Risk Mitigation, Resource Allocation, Technical Leadership, Software Development Life Cycle, System Integration, Quality Assurance, Analytical Problem Solving, International Travel, Technical Documentation, Change Management, Scheduling, Communication

Specialization
Requires a PMP or Prince2 certification with over 7 years of experience and an engineering degree or technical background. Candidates must be familiar with aviation IT, software safety assurance guidelines, and ISO 9001:2015 quality processes.

Experience Required
Minimum 5 year(s)

Assistant Project Manager at Vortex Companies, LLC

Williamsburg, Virginia, United States - Full Time

Skills Needed
Project Coordination, Bid Preparation, Cost Tracking, Budget Monitoring, Contract Administration, Scheduling, Rfi Tracking, Submittal Management, Vendor Coordination, Microsoft Office, Erp Systems, Problem Solving, Communication, Organization, Construction Workflows, Field Logistics

Specialization
A bachelor's degree in Construction Management or Engineering is preferred, along with 1-3 years of experience in construction or infrastructure. Candidates should possess strong organizational skills and proficiency in Microsoft Office and project management software.

Experience Required
Minimum 2 year(s)

Warehouse Associate at RAS Logistics LLC

Hooksett, New Hampshire, United States - Full Time

Skills Needed
Inventory Management, Pallet Jack Operation, Order Inspection, Warehouse Safety, Physical Stamina, Attention To Detail, Logistics, Receiving

Specialization
Previous warehouse or logistics experience is preferred. Candidates must be able to repeatedly lift up to 100 lbs and perform physical tasks in a warehouse environment.

Warehouse Associate at RAS Logistics LLC

Roanoke, Virginia, United States - Full Time

Skills Needed
Inventory Management, Pallet Jack Operation, Order Inspection, Warehouse Safety, Physical Stamina, Attention To Detail, Logistics, Receiving And Shipping

Specialization
Candidates should have previous warehouse or logistics experience and the ability to repeatedly lift up to 100 lbs. Basic knowledge of warehouse equipment and a commitment to reliable attendance are required.

Продавець-консультант ТЦ «Республіка» at JYSK

Kyiv, , Ukraine - Full Time

Skills Needed
Customer Service, Inventory Management, Sales Analysis, Knowledge Transfer, Retail Operations, Merchandising

Specialization
Candidates should be ready to help customers and manage department operations. A desire for career growth and the ability to work in a fast-paced environment are required.

ASSOCIATE PROJECT MANAGER at Anderson Dahlen Inc

Ramsey, Minnesota, United States - Full Time

Skills Needed
Project Management, Microsoft Excel, Data Analysis, Erp Systems, Engineering Drawing Interpretation, Budget Tracking, Stakeholder Communication, Scheduling, Risk Management, Change Order Management, Supply Chain Coordination, Operational Cadence

Specialization
A bachelor's degree in Engineering, Supply Chain, Business, or a related technical field is required, with 0-2 years of experience. Proficiency in Microsoft Excel and the ability to read engineering drawings are essential requirements.

Warehouse Associate at RAS Logistics LLC

Richmond, Virginia, United States - Full Time

Skills Needed
Inventory Management, Pallet Jack Operation, Order Inspection, Warehouse Safety, Physical Stamina, Attention To Detail, Logistics

Warehouse Positions at Spartan Logistics

Darlington, South Carolina, United States - Full Time

Skills Needed
Warehouse Operations, Logistics, Dependability, Teamwork, Safety Compliance

Specialization
Seeking hardworking and dependable individuals interested in warehouse career opportunities. Candidates must be available for 12-hour shift schedules.

Manager Projectbeheersing at Strukton Nederland

Breda, North Brabant, Netherlands - Full Time

Skills Needed
Project Control, Analytical Thinking, Communication Skills, Relatics, Document Management Systems, Quality Systems, Financial Reporting, Process Monitoring, Verification & Validation, Civil Engineering, Construction Management, Stakeholder Management, Proactive Problem Solving, Dutch Language Proficiency

Specialization
Requires a Bachelor's or Master's degree in Civil Engineering, Construction Management, or Technical Business Administration. Candidates must have experience as a project coordinator or controller in civil infrastructure, specifically in road or concrete construction.

Experience Required
Minimum 5 year(s)

Content Moderator - Korean - Bangkok at Teleperformance

Bangkok, , Thailand - Full Time

Skills Needed
Content Moderation, Indonesian Language, English Language, Data Annotation, Analytical Thinking, Critical Thinking, Microsoft Office, Typing Speed, Social Media Platforms, Policy Compliance

Specialization
Requires a bachelor's degree and fluency in Indonesian and English (B2 level). Candidates must be able to work in a 24/7 shift rotation and possess strong attention to detail.

Senior Manager, CMC Regulatory Affairs at Moderna

Norwood, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Aug, 26

Salary

209400.0

Posted On

16 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CMC Regulatory Affairs, Regulatory Strategy, IND/CTA/BLA/MAA Submissions, CTD Format, cGMP, Biologics, Health Authority Interaction, Change Control Evaluation, Regulatory Compliance, Technical Writing, Project Management, Analytical Development

Industry

Biotechnology Research

Description

The Role: The candidate in this role will be based at the Norwood MA site and will be responsible for preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of global products. This position will lead and support all regulatory activities to provide high quality CMC sections of regulatory documentation. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients. Here’s What You’ll Do: Support effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks Provide guidance for regulatory CMC aspects of product development projects Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines Contribute in the Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions Support regulatory processes and procedures to support CMC components of regulatory submissions Support the creation and maintenance of CMC submission templates Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls Provides interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs Here’s What You’ll Need (Basic Qualifications) MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus 5+ years of experience in focused Regulatory CMC, preferably Biologics based Multidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases) Strong knowledge of current US, EU and ROW regulations Strong knowledge of cGMP Strong experience with CTD format and content regulatory filings Exceptional written and oral communication Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras The salary range for this role is $130,800.00 - $209,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-KF1 - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

Responsibilities

Responsible for preparing and overseeing CMC and Quality related agency correspondence and regulatory applications for global products. The role involves leading regulatory activities to ensure high-quality CMC sections and providing guidance to manufacturing and quality teams.

Senior Manager, CMC Regulatory Affairs at Moderna

Norwood, Massachusetts, United States - Full Time

Experience Required
Minimum 10 year(s)

Caregiver Needed in University Park, IL – Bring Comfort, Companionship, and at RES Consultant Group

University Park, Illinois, United States - Full Time

Pediatric Acute Physical Therapist I-Dallas Medical Center at Children's Health StarCenters

Dallas, Texas, United States - Full Time

Skills Needed
Physical Therapy Evaluation, Pediatric Care, Acute Care, Treatment Planning, Interdisciplinary Collaboration, Patient Documentation, Discharge Planning, Patient Re Evaluation

Behavioral Health Therapist- Anderson at Community Health Network

Anderson, Indiana, United States - Full Time

Experience Required
Minimum 2 year(s)

Substance Abuse Counselor I at MTC

Huntsville, Texas, United States - Full Time

Veterinary Assistant at Independence Veterinary Clinic

Charlotte, North Carolina, United States - Full Time

Experience Required
Minimum 2 year(s)

OB/GYN Gynecologist - Panorama City at Southern California Permanente Medical Group

Santa Clarita, California, United States - Full Time

Skills Needed
Gynecology, Obstetrics, Patient Care, Clinical Leadership, Medical Diagnosis, Treatment Planning

Specialization
Candidates must be Board Certified or Board Eligible in OB/GYN. Must pass a background check and drug screen.

Experience Required
Minimum 5 year(s)

General Superintendent – Miscellaneous Metals at Qualdoc

, Virginia, United States - Full Time

Experience Required
Minimum 10 year(s)

Senior Director, Global Order to Cash at Versant

Englewood Cliffs, New Jersey, United States - Full Time

Experience Required
Minimum 10 year(s)

Manager, NAV Oversight at IQ-EQ

Hyderabad, Telangana, India - Full Time

Experience Required
Minimum 10 year(s)

Technical Project Manager at Searidge Technologies

, , - Full Time

Experience Required
Minimum 5 year(s)

Assistant Project Manager at Vortex Companies, LLC

Williamsburg, Virginia, United States - Full Time

Experience Required
Minimum 2 year(s)

Warehouse Associate at RAS Logistics LLC

Hooksett, New Hampshire, United States - Full Time

Skills Needed
Inventory Management, Pallet Jack Operation, Order Inspection, Warehouse Safety, Physical Stamina, Attention To Detail, Logistics, Receiving

Specialization
Previous warehouse or logistics experience is preferred. Candidates must be able to repeatedly lift up to 100 lbs and perform physical tasks in a warehouse environment.

Warehouse Associate at RAS Logistics LLC

Roanoke, Virginia, United States - Full Time

Skills Needed
Inventory Management, Pallet Jack Operation, Order Inspection, Warehouse Safety, Physical Stamina, Attention To Detail, Logistics, Receiving And Shipping

Продавець-консультант ТЦ «Республіка» at JYSK

Kyiv, , Ukraine - Full Time

Skills Needed
Customer Service, Inventory Management, Sales Analysis, Knowledge Transfer, Retail Operations, Merchandising

Specialization
Candidates should be ready to help customers and manage department operations. A desire for career growth and the ability to work in a fast-paced environment are required.

ASSOCIATE PROJECT MANAGER at Anderson Dahlen Inc

Ramsey, Minnesota, United States - Full Time

Warehouse Associate at RAS Logistics LLC

Richmond, Virginia, United States - Full Time

Skills Needed
Inventory Management, Pallet Jack Operation, Order Inspection, Warehouse Safety, Physical Stamina, Attention To Detail, Logistics

Warehouse Positions at Spartan Logistics

Darlington, South Carolina, United States - Full Time

Skills Needed
Warehouse Operations, Logistics, Dependability, Teamwork, Safety Compliance

Specialization
Seeking hardworking and dependable individuals interested in warehouse career opportunities. Candidates must be available for 12-hour shift schedules.

Manager Projectbeheersing at Strukton Nederland

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Experience Required
Minimum 5 year(s)

Content Moderator - Korean - Bangkok at Teleperformance

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Requires a bachelor's degree and fluency in Indonesian and English (B2 level). Candidates must be able to work in a 24/7 shift rotation and possess strong attention to detail.

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