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Team member, Regulatory Affairs at Syngene
, karnataka, India - Full Time
Skills Needed
Regulatory Affairs, Cmc Regulatory, Ectd, Quality Management System, Investigational Medicinal Products, Marketing Authorization, Biologics, Small Molecule, Technical Inputs, Regulatory Compliance, Project Management, Standard Operating Procedures, English Proficiency, Risk Assessment, Training, Documentation
Specialization
Candidates must have 6 to 13 years of experience in CMC Regulatory Affairs, particularly for small molecule APIs and formulations. A B.Pharm or M.Pharm degree is required, along with proficiency in English and hands-on experience with eCTD submissions.
Experience Required
Minimum 5 year(s)
CMC Regulatory Affairs Manager at Katalyst Healthcares Life Sciences
Baltimore, MD 21201, USA - Full Time
Skills Needed
Collaboration, Chemistry, Biologics, Project Management Skills, Pharmaceutical Industry, Blas, Regulatory Submissions, Pharmaceutical Sciences, Maas, Cmc, Regulatory Requirements, Regulatory Affairs, Small Molecules
Specialization
Chemistry
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Regulatory Affairs Associate I at Teva Pharmaceutical Industries Ltd. - Israel
Navi Mumbai, maharashtra, India - Full Time
Skills Needed
Regulatory Affairs, Data Management, Quality Control, Pharmaceutical Industry, Regulatory Dossier, Data Integrity, Stakeholder Engagement, Project Contributions, Regulatory Data Analytics, Work Instructions, Sops, Registration Data, Regulatory Technology, Data Structures, Business Goals, Operational Activities
Specialization
A Bachelor's or Master's degree in Life Sciences or Information Technology is required, with 1-3 years of experience in regulatory operations or affairs preferred. Candidates should have an interest in pharmaceutical regulatory affairs and an aptitude for regulatory data management.
Industrial Affairs Officer F/H at SERB
Paris, Ile-de-France, France - Full Time
Skills Needed
Pharmaceutical Production, Quality Assurance, Technical Documentation, Problem Solving, Statistical Analysis, Communication Skills, Project Management, Regulatory Compliance, Supplier Qualification, Process Validation, Analytical Method Validation, Team Collaboration, Attention To Detail, Change Control, Gxp Systems, Ich Guidelines
Specialization
Candidates should have experience in pharmaceutical production or related fields, familiarity with GxP systems, and strong communication skills. A Master's degree in a relevant field and proficiency in English are required.
Experience Required
Minimum 2 year(s)
Senior Federal Affairs Manager at MAPLEBEAR INC D/B/A INSTACART
Washington, District of Columbia, United States - Full Time
Skills Needed
Federal Government Relations, Policy Advocacy, Legislative Strategy, Regulatory Processes, Stakeholder Engagement, Public Policy, Strategic Thinking, Oral Presentation Skills, Written Presentation Skills, Resourcefulness, Entrepreneurial Mindset, E Commerce Knowledge, Labor Policy Expertise, Workforce Policy Expertise, Political Campaigns, Community Engagement
Specialization
Candidates should have over 8 years of experience in federal government or corporate government relations, with established relationships in Congress and the Executive Branch. A deep understanding of Congressional lawmaking and regulatory processes is essential, along with strong strategic thinking and communication skills.
Experience Required
Minimum 10 year(s)
Head of Corporate Affairs UK&I at Ipsen Ltd
London W2, England, United Kingdom - Full Time
Skills Needed
Thinking Skills, Public Policy, English, Public Relations, Communications, Government, Internal Communications, Journalism, Political Science, Life Sciences
Specialization
Public relations political science public policy communications journalism business administration or related field
Qualification
Graduate
Regulatory Affairs Coordinator at Nassau Candy
Hicksville, NY 11801, USA - Full Time
Skills Needed
Chemistry, Outlook, Excel, Food Technology, Nutrition, Biology, Microsoft Office, Food Science
Qualification
Graduate
Experience Required
Minimum 1 year(s)
Regulatory Affairs Specialists at GL Healthcare Advisors
United States, , USA - Full Time
Skills Needed
Life Sciences, Oncology, Immunology, Ema, Regulatory Submissions, Regulatory Affairs
Qualification
MBA
Experience Required
Minimum 8 year(s)
Regulatory Affairs Associate II at Teva Pharmaceutical Industries Ltd. - Israel
Navi Mumbai, maharashtra, India - Full Time
Skills Needed
Regulatory Affairs, Project Management, Data Analysis, Business Process Mapping, Change Management, Cross Functional Leadership, Regulatory Compliance, Pharmaceutical Industry Knowledge, Data Integrity, Communication Skills, Regulatory Requirements, System Design, Stakeholder Engagement, Technical Documentation, Auditing, Capa Planning
Specialization
Candidates must have a Bachelor's degree in Life Sciences or Information Technology and 3 to 5 years of experience in the pharmaceutical industry, specifically in Regulatory Affairs. Experience in leading project teams and managing regulatory data is essential.
Experience Required
Minimum 2 year(s)
Regulatory Affairs Coordinator at Phibro Animal Health
, Jerusalem District, Israel - Full Time
Skills Needed
Regulatory Affairs, Database Management, Documentation, Report Preparation, Artwork Coordination, Problem Solving, Attention To Detail, Communication, Graphic Design, Analytical Skills, International Relations, Biology, Chemistry, Quality Assurance, R&D, Business Software
Specialization
Candidates should have a Bachelor's degree in Biology, Chemistry, or equivalent, along with 1-2 years of experience in Regulatory Affairs or related fields. A high level of English is necessary, and knowledge of graphic design is ideal.
Senior advisor, Global affairs at Caisse de dpt et placement du Qubec
London, England, United Kingdom - Full Time
Skills Needed
Disabilities, Groups, Enrichment
Specialization
International business finance or economics
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Regulatory Affairs Associate II at RIVERPOINT MEDICAL LLC
Portland, OR 97232, USA - Full Time
Skills Needed
Regulatory Affairs, Medical Devices, Customer Service, Probability, Regulatory Submissions, Regulations, Post Market Surveillance, Psur
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Director of Regulatory Affairs at Beacon Hill Staffing Group
St. Louis, Missouri, USA - Full Time
Skills Needed
Strategy, Staffing Services, Compilation, Emerging Growth Companies, Life Science, Eligibility, Summary Reports, Creativity, Clinical Protocols, Pharmaceutical Industry, Search, Continuous Improvement, Disabilities, Life Sciences, Completion, Biology, Chemistry
Specialization
Chemistry pharmacy biology or other life science plus direct experience managing regulatory activities
Qualification
BSc
Head of Corporate Legal Affairs at SYSPRO
London, England, United Kingdom - Full Time
Skills Needed
Risk Analysis, Time Management, Stakeholder Management, International Law, Corporate Law, Corporate Governance, Mitigation
Specialization
Law
Qualification
Graduate
Experience Required
Minimum 10 year(s)
Sr Manager, Regulatory Affairs at Baxter
Deerfield, IL 60015, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Director of Government Affairs at Abacus Corporation
Richmond, VA 23219, USA - Full Time
Skills Needed
Agriculture, Communications, Event Planning
Specialization
Agriculture, Business, Communications
Qualification
Graduate
Sr Associate Regulatory Affairs at Breckenridge Pharmaceutical Inc
Berkeley Heights, NJ 07922, USA - Full Time
Skills Needed
Biology, Combination Products, Regulatory Affairs, Chemistry
Specialization
Pharmacy chemistry biology or related field required
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Senior Business Affairs Manager at Rocket
Detroit, MI 48226, USA - Full Time
Skills Needed
Multitasking, Digital Asset Management, Contract Negotiation, Afm, Payroll, Time Management
Qualification
Graduate
Stakeholder Affairs Coordinator at CCTSCPRST
Ottawa, ON K1P 5H9, Canada - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Sr. Scientific Affairs Manager at O Positiv
Santa Monica, California, USA - Full Time
Skills Needed
Human Physiology, Food Science, Communication Skills, Working Experience, Technical Research, Functional Foods, Los Angeles
Specialization
A related science field (e.g biochemistry nutritional science human physiology food science pharmaceutical science etc
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Team member, Regulatory Affairs at Syngene
, karnataka, India -
Full Time

Start Date

Immediate

Expiry Date

27 Dec, 25

Salary

0.0

Posted On

28 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Affairs, CMC Regulatory, eCTD, Quality Management System, Investigational Medicinal Products, Marketing Authorization, Biologics, Small Molecule, Technical Inputs, Regulatory Compliance, Project Management, Standard Operating Procedures, English Proficiency, Risk Assessment, Training, Documentation

Industry

Pharmaceutical Manufacturing

Description
JOB DESCRIPTION   Job Title: Junior Manager - Regulatory Affairs Job Location: Syngene International Limited, Biocon SEZ, Biocon Park, Plot No. 2, 3, 4 & 5, Bommasandra Industrial Area, Jigani Link Road, Bengaluru, Karnataka 560099, India (IND)   About Syngene :  Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific  services from early discovery to commercial supply.   At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit   Mandatory expectation for all roles as per Syngene safety guidelines   Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene’ s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time   Core Purpose of the Role: The candidate will combine his/her knowledge of scientific & regulatory guidelines, CMC regulatory and filing skills to ensure successful filing, registrations, and post-approval maintenance for the intended countries. The candidate will lead eCTD filing, Regulatory DMS and QMS system activities. Role Accountabilities The candidate’s contribution will help bring the much-needed therapeutics to the unmet need of the patients, thereby positively impacting mankind. The candidate will be accountable for: Pivotal CMC Regulatory support throughout the development cycle of the novel drugs space and generics space, including small molecule & biologics, in marketing authorization / DMF filing and lifecycle management, predominantly for Developed countries and for certain Emerging countries, based on the market requirement. Research on regulatory requirements for new molecules / category of products based on business need in time-bound manner and provide feasibility/technical inputs to the team. Identify requirements for IND, NDA, MAA, ANDA, ANADA and other Dossiers, prepare checklists, ensuring regulatory compliance. Interact with stakeholders, collate necessary document, Review plant and R&D documentation such as development reports, BMR, BPR, Specifications, method validation, process validation etc, conduct thorough regulatory assessment, identify risks, communicate to team and client, and recommend corrective measures. Plan and develop sections, compile, author, and Publish eCTD Dossiers. Ensure timely submission. Respond to regulatory agencies on a timely basis. Responsible for Regulatory project management. Provide Regulatory strategy inputs to the team and the clients. Assessing the regulatory requirements for various business requirements as and when needed. Maintain all regulatory filings, Product Marketing authorization renewals to ensure continuous validity. Maintain, and update product dossiers/DMFs as required to meet changes in internal systems, changes in regulatory guidelines. Maintain Quality Agreement Tracker, prepare Quality Agreement Checklists, and review New Quality Agreements. Train staff in regulatory policies or procedures. Develop and maintain standard operating procedures or local working practices. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. Attend training on environment, health, and safety (EHS) measures imparted by the company. Traveling to other sites within Karnataka if necessary, though travel requirements are minimal. Leadership Capabilities   Syngene Values   All employees will consistently demonstrate alignment with our core values    Excellence  Integrity  Professionalism   Specific requirements for this role   Experience Demonstrated Capability Education   Experience   Must have experience of 6 to 13 years in CMC Regulatory Affairs for small molecule API / Formulations (preferably in injectables) for US/Europe/Developed Markets Must have hands-on experience in investigational medicinal products and marketing authorization. Experience in Biologicals /ADC / veterinary drugs is a definite plus.   Skills and Capabilities High-level English Proficiency in reading, writing, and communication Hands-on Experience in eCTD. Experience in RDMS, EDMS & QMS is definite plus. Thorough understanding of CMC (API & Drug Product) and skill in regulatory interpretations and application     Education B.Pharm / M. Pharm / Life sciences degree with minimum 5 + years of working experience with Pharmaceutical / Life science.  Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities

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Responsibilities
The candidate will provide pivotal CMC regulatory support throughout the development cycle of novel drugs and generics, ensuring successful filings and compliance. They will interact with stakeholders, manage regulatory submissions, and maintain product dossiers to meet regulatory requirements.
Team member, Regulatory Affairs at Syngene
, karnataka, India - Full Time
Skills Needed
Regulatory Affairs, Cmc Regulatory, Ectd, Quality Management System, Investigational Medicinal Products, Marketing Authorization, Biologics, Small Molecule, Technical Inputs, Regulatory Compliance, Project Management, Standard Operating Procedures, English Proficiency, Risk Assessment, Training, Documentation
Specialization
Candidates must have 6 to 13 years of experience in CMC Regulatory Affairs, particularly for small molecule APIs and formulations. A B.Pharm or M.Pharm degree is required, along with proficiency in English and hands-on experience with eCTD submissions.
Experience Required
Minimum 5 year(s)
CMC Regulatory Affairs Manager at Katalyst Healthcares Life Sciences
Baltimore, MD 21201, USA - Full Time
Skills Needed
Collaboration, Chemistry, Biologics, Project Management Skills, Pharmaceutical Industry, Blas, Regulatory Submissions, Pharmaceutical Sciences, Maas, Cmc, Regulatory Requirements, Regulatory Affairs, Small Molecules
Specialization
Chemistry
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Regulatory Affairs Associate I at Teva Pharmaceutical Industries Ltd. - Israel
Navi Mumbai, maharashtra, India - Full Time
Skills Needed
Regulatory Affairs, Data Management, Quality Control, Pharmaceutical Industry, Regulatory Dossier, Data Integrity, Stakeholder Engagement, Project Contributions, Regulatory Data Analytics, Work Instructions, Sops, Registration Data, Regulatory Technology, Data Structures, Business Goals, Operational Activities
Specialization
A Bachelor's or Master's degree in Life Sciences or Information Technology is required, with 1-3 years of experience in regulatory operations or affairs preferred. Candidates should have an interest in pharmaceutical regulatory affairs and an aptitude for regulatory data management.
Industrial Affairs Officer F/H at SERB
Paris, Ile-de-France, France - Full Time
Skills Needed
Pharmaceutical Production, Quality Assurance, Technical Documentation, Problem Solving, Statistical Analysis, Communication Skills, Project Management, Regulatory Compliance, Supplier Qualification, Process Validation, Analytical Method Validation, Team Collaboration, Attention To Detail, Change Control, Gxp Systems, Ich Guidelines
Specialization
Candidates should have experience in pharmaceutical production or related fields, familiarity with GxP systems, and strong communication skills. A Master's degree in a relevant field and proficiency in English are required.
Experience Required
Minimum 2 year(s)
Senior Federal Affairs Manager at MAPLEBEAR INC D/B/A INSTACART
Washington, District of Columbia, United States - Full Time
Skills Needed
Federal Government Relations, Policy Advocacy, Legislative Strategy, Regulatory Processes, Stakeholder Engagement, Public Policy, Strategic Thinking, Oral Presentation Skills, Written Presentation Skills, Resourcefulness, Entrepreneurial Mindset, E Commerce Knowledge, Labor Policy Expertise, Workforce Policy Expertise, Political Campaigns, Community Engagement
Specialization
Candidates should have over 8 years of experience in federal government or corporate government relations, with established relationships in Congress and the Executive Branch. A deep understanding of Congressional lawmaking and regulatory processes is essential, along with strong strategic thinking and communication skills.
Experience Required
Minimum 10 year(s)
Head of Corporate Affairs UK&I at Ipsen Ltd
London W2, England, United Kingdom - Full Time
Skills Needed
Thinking Skills, Public Policy, English, Public Relations, Communications, Government, Internal Communications, Journalism, Political Science, Life Sciences
Specialization
Public relations political science public policy communications journalism business administration or related field
Qualification
Graduate
Regulatory Affairs Coordinator at Nassau Candy
Hicksville, NY 11801, USA - Full Time
Skills Needed
Chemistry, Outlook, Excel, Food Technology, Nutrition, Biology, Microsoft Office, Food Science
Qualification
Graduate
Experience Required
Minimum 1 year(s)
Regulatory Affairs Specialists at GL Healthcare Advisors
United States, , USA - Full Time
Skills Needed
Life Sciences, Oncology, Immunology, Ema, Regulatory Submissions, Regulatory Affairs
Qualification
MBA
Experience Required
Minimum 8 year(s)
Regulatory Affairs Associate II at Teva Pharmaceutical Industries Ltd. - Israel
Navi Mumbai, maharashtra, India - Full Time
Skills Needed
Regulatory Affairs, Project Management, Data Analysis, Business Process Mapping, Change Management, Cross Functional Leadership, Regulatory Compliance, Pharmaceutical Industry Knowledge, Data Integrity, Communication Skills, Regulatory Requirements, System Design, Stakeholder Engagement, Technical Documentation, Auditing, Capa Planning
Specialization
Candidates must have a Bachelor's degree in Life Sciences or Information Technology and 3 to 5 years of experience in the pharmaceutical industry, specifically in Regulatory Affairs. Experience in leading project teams and managing regulatory data is essential.
Experience Required
Minimum 2 year(s)
Regulatory Affairs Coordinator at Phibro Animal Health
, Jerusalem District, Israel - Full Time
Skills Needed
Regulatory Affairs, Database Management, Documentation, Report Preparation, Artwork Coordination, Problem Solving, Attention To Detail, Communication, Graphic Design, Analytical Skills, International Relations, Biology, Chemistry, Quality Assurance, R&D, Business Software
Specialization
Candidates should have a Bachelor's degree in Biology, Chemistry, or equivalent, along with 1-2 years of experience in Regulatory Affairs or related fields. A high level of English is necessary, and knowledge of graphic design is ideal.
Senior advisor, Global affairs at Caisse de dpt et placement du Qubec
London, England, United Kingdom - Full Time
Skills Needed
Disabilities, Groups, Enrichment
Specialization
International business finance or economics
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Regulatory Affairs Associate II at RIVERPOINT MEDICAL LLC
Portland, OR 97232, USA - Full Time
Skills Needed
Regulatory Affairs, Medical Devices, Customer Service, Probability, Regulatory Submissions, Regulations, Post Market Surveillance, Psur
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Director of Regulatory Affairs at Beacon Hill Staffing Group
St. Louis, Missouri, USA - Full Time
Skills Needed
Strategy, Staffing Services, Compilation, Emerging Growth Companies, Life Science, Eligibility, Summary Reports, Creativity, Clinical Protocols, Pharmaceutical Industry, Search, Continuous Improvement, Disabilities, Life Sciences, Completion, Biology, Chemistry
Specialization
Chemistry pharmacy biology or other life science plus direct experience managing regulatory activities
Qualification
BSc
Head of Corporate Legal Affairs at SYSPRO
London, England, United Kingdom - Full Time
Skills Needed
Risk Analysis, Time Management, Stakeholder Management, International Law, Corporate Law, Corporate Governance, Mitigation
Specialization
Law
Qualification
Graduate
Experience Required
Minimum 10 year(s)
Sr Manager, Regulatory Affairs at Baxter
Deerfield, IL 60015, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Director of Government Affairs at Abacus Corporation
Richmond, VA 23219, USA - Full Time
Skills Needed
Agriculture, Communications, Event Planning
Specialization
Agriculture, Business, Communications
Qualification
Graduate
Sr Associate Regulatory Affairs at Breckenridge Pharmaceutical Inc
Berkeley Heights, NJ 07922, USA - Full Time
Skills Needed
Biology, Combination Products, Regulatory Affairs, Chemistry
Specialization
Pharmacy chemistry biology or related field required
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Senior Business Affairs Manager at Rocket
Detroit, MI 48226, USA - Full Time
Skills Needed
Multitasking, Digital Asset Management, Contract Negotiation, Afm, Payroll, Time Management
Qualification
Graduate
Stakeholder Affairs Coordinator at CCTSCPRST
Ottawa, ON K1P 5H9, Canada - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Sr. Scientific Affairs Manager at O Positiv
Santa Monica, California, USA - Full Time
Skills Needed
Human Physiology, Food Science, Communication Skills, Working Experience, Technical Research, Functional Foods, Los Angeles
Specialization
A related science field (e.g biochemistry nutritional science human physiology food science pharmaceutical science etc
Qualification
Graduate
Experience Required
Minimum 5 year(s)