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Regulatory Affairs Associate Ii

4-7 years
Not Disclosed
10 Nov. 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Affairs Associate II – Teva Pharmaceuticals (Navi Mumbai, India)

Location: Navi Mumbai, Maharashtra, India
Job Category: Regulatory Affairs / Pharmaceutical
Experience Required: 4–7 years in regulatory affairs or relevant pharmaceutical field
Job ID: 64982


About Teva Pharmaceuticals

Teva Pharmaceuticals is a global leader in generic and specialty medicines, committed to making healthcare more affordable and accessible. With operations in nearly 60 countries, Teva manufactures many products listed on the World Health Organization’s Essential Medicines List, impacting the daily lives of over 200 million people worldwide. Join Teva to contribute to improving global health through regulatory excellence and strategic support.


Job Opportunity

As a Regulatory Affairs Associate II, you will play a key role in managing marketing authorizations and post-approval changes for products in the UK, Ireland, and selected EU markets. You will ensure regulatory submissions are accurate, timely, and compliant with local and international legislation, while supporting cross-functional teams, stakeholders, and clients.


Key Responsibilities

  • Prepare, compile, review, and submit post-approval changes, including variations, renewals, PIQU submissions, and responses to health authority queries.

  • Provide administrative support for new marketing authorization applications in the UK (GB/NI) and support EU submissions where required.

  • Maintain registration documentation and electronic databases in compliance with Teva SOPs and internal procedures.

  • Collaborate with Line Manager to prioritize and manage multiple projects, ensuring deliverables are met within stipulated timelines.

  • Maintain up-to-date knowledge of current and pending regulatory legislation and guidance in the UK, Ireland, and EU.

  • Support general regulatory operations, including finance-related tasks such as raising POs and invoice approvals, as needed.

  • Liaise with internal teams, including QA, Manufacturing, Packaging, Portfolio Management, Medical Affairs, Pharmacovigilance, and Supply Chain to ensure regulatory compliance.

  • Maintain professional communication with external stakeholders such as MHRA, HPRA, customers, and suppliers.


Qualifications and Experience Required

  • M. Pharma or equivalent degree in a relevant pharmaceutical field.

  • 4–7 years of experience in regulatory affairs within the pharmaceutical industry.

  • Familiarity with UK, Ireland, or EU regulatory procedures is highly desirable.

  • Understanding of pharmaceutical company operations including regulatory, quality, and project management functions.


Key Skills

  • Excellent oral and written communication skills.

  • Strong analytical and problem-solving abilities.

  • Ability to work under pressure and manage tight deadlines.

  • Effective time management and organizational skills.

  • Ability to work independently and proactively.

  • Proficient in computer literacy and relevant software tools.


Why Join Teva Pharmaceuticals?

  • Work with a diverse, global team driving accessible healthcare solutions.

  • Contribute to maintaining compliance and regulatory excellence across multiple markets.

  • Gain exposure to a wide portfolio of regulated pharmaceutical products.

  • Collaborate with internal and external stakeholders, enhancing your professional growth and expertise.