Regulatory Affairs Associate II – EU Post-Approval
Company: Teva Pharmaceuticals
Location: Navi Mumbai, Maharashtra, India (400706)
Job Type: Full-Time
Category: Regulatory Affairs / Pharmaceutical Compliance
Experience Required: 4–6 years
Company Overview
Teva Pharmaceuticals is a global leader in generic and specialty medicines, dedicated to making healthcare more affordable and accessible. Operating in nearly 60 countries, Teva reaches over 200 million patients worldwide daily, including through medicines on the World Health Organization’s Essential Medicines List. Teva fosters a diverse and inclusive work environment while driving scientific innovation across global pharmaceutical operations.
Job Summary
Teva is seeking a Regulatory Affairs Associate II with EU post-approval experience to manage, coordinate, and submit high-quality regulatory documentation in compliance with European legislation and Teva’s internal standards. The role involves supporting regulatory strategy, change control, and compliance for assigned products while collaborating with cross-functional teams across Europe.
The ideal candidate has a Master’s degree in Pharmacy, Science, or Life Sciences, strong knowledge of EU regulatory procedures, and hands-on experience managing post-approval regulatory submissions.
Key Responsibilities
Regulatory Submission & Compliance
Prepare, compile, review, and submit regulatory documentation for all required post-approval activities in alignment with EU legislation and internal standards.
Ensure Marketing Authorization (MA) compliance with applicable laws, regulations, and internal business requirements.
Prioritize, plan, and monitor submissions for assigned procedures, documenting progress and informing stakeholders.
Regulatory Support & Strategy
Provide regulatory support to project teams, stakeholders, and European units for assigned product portfolios.
Contribute to the development and implementation of regulatory strategies for defined projects.
Communicate effectively with internal Teva departments and European regulatory agencies regarding pending and proposed submissions.
Maintain awareness of current and pending EU regulatory legislation, guidance documents, and industry best practices.
Process Improvement & Collaboration
Support defined departmental processes and propose improvements where applicable.
Monitor and ensure adherence to the change control process and CMC compliance.
Collaborate with cross-functional teams to ensure smooth execution of regulatory activities and timelines.
Education & Experience Requirements
Required Degree: Master’s in Pharmacy, Science, or Life Sciences
Experience:
4–6 years in Regulatory Affairs with EU post-approval focus
Hands-on experience in EU member states, familiar with Mutual Recognition, Decentralized, and Centralized Procedures
Knowledge of pharmaceutical company processes and CMC/change control requirements
Skills & Competencies
Strong knowledge of EU regulatory procedures and post-approval compliance requirements
Excellent oral and written communication skills in English
Effective time management and ability to work under pressure with tight deadlines
Analytical skills for documentation and data management
Negotiation, presentation, and stakeholder management skills
Proficiency in computer applications relevant to regulatory documentation
Why Join Teva
Work for a global pharmaceutical leader impacting millions of patients worldwide
Contribute to regulatory excellence and compliance in EU markets
Collaborate with cross-functional and multinational teams
Opportunities for career growth in Regulatory Affairs, Quality, and Pharmaceutical Operations
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