Regulatory Affairs Associate II – Teva Pharmaceuticals (Navi Mumbai, India)
Job ID: 64982
Location: Navi Mumbai, Maharashtra
Employment Type: Full-time
About the Company
Teva Pharmaceuticals is a global leader in generic and specialty medicines, delivering high-quality, affordable healthcare solutions to millions of patients worldwide. With operations across nearly 60 countries and a diverse, international workforce, Teva is recognized for its strong contribution to the WHO Essential Medicines List and its mission to improve global health outcomes.
Role Overview
The Regulatory Affairs Associate II will support regulatory submissions and lifecycle management activities for the UK and Ireland markets. This role ensures timely approvals, regulatory compliance, and ongoing maintenance of the product license portfolio. The position requires strong coordination with regulatory leadership, project teams, stakeholders, and cross-functional departments.
Key Responsibilities
Prepare, compile, review, and submit high-quality post-approval applications including variations, renewals, PIQU submissions, and responses to authority queries.
Provide administrative support for new Marketing Authorization Applications (UK GB/NI).
Support national regulatory activities related to EU variations and new applications as per established timelines.
Maintain regulatory documentation and update electronic databases according to internal SOPs and work instructions.
Coordinate with the Line Manager to plan, prioritize, and monitor project timelines.
Ensure approvals for assigned products are achieved within regulatory deadlines.
Support Teva project teams, stakeholders, and customers with regulatory inputs.
Maintain awareness of evolving regulatory legislation, guidelines, and market requirements.
Assist in general UK/IE Regulatory Affairs operations, including financial processes such as raising purchase orders and invoice approvals.
Perform additional duties assigned by senior regulatory personnel.
Major Challenges
Managing a broad and diverse license estate.
Meeting deadlines while addressing urgent issues and shifting priorities.
Understanding evolving regulatory frameworks and adapting to rapid changes.
Required Qualifications and Experience
Education: M. Pharma
Experience: 4 to 7 years in Regulatory Affairs or related pharmaceutical functions.
Preferred Knowledge:
Experience with UK, Ireland, or EU regulatory procedures.
Basic understanding of pharmaceutical operations including manufacturing, QA, QC, packaging, and supply chain.
Required Skills
Strong verbal and written communication abilities.
Ability to perform under pressure and manage tight timelines.
Effective time management and organizational capabilities.
Ability to work independently with minimal supervision.
Analytical mindset and data-driven approach.
Proficiency in standard computer applications and regulatory systems.
Key Internal Collaborations
UK/IE Regulatory Affairs
EU Regulatory Affairs
Manufacturing, Packaging, QC, QA
Portfolio and Project Management
Business Development
Product Marketing and Management
Supply Chain, EPD
Medical Affairs, Pharmacovigilance, Medical Information
Procurement and Artwork Teams
External Interactions
MHRA
HPRA
Customers and suppliers
Reporting Structure
Reports to: Associate Director, Senior Manager, or Manager – Regulatory Affairs
Equal Opportunity Commitment
Teva Pharmaceuticals is committed to providing equal employment opportunities without discrimination based on age, race, religion, sex, disability, pregnancy, medical status, gender identity, sexual orientation, veteran status, national origin, or any other legally protected category. Accommodations during the recruitment process will be provided upon request to ensure an inclusive candidate experience.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Istanbul | Turkey |Norway :
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China | Quarry Bay |Liaoning :
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Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
Montreal |Brussels :
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Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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