Job Title: Regulatory Affairs Associate II – EU Post-Approval
Location: Navi Mumbai, India (400706)
Company: Teva Pharmaceuticals
Job ID: 65464
Employment Type: Full-Time
Industry: Regulatory Affairs | EU Regulatory | Pharmaceuticals | CMC | Post-Approval Variations
Teva Pharmaceuticals is seeking an experienced Regulatory Affairs Associate II to join its Regulatory Affairs team in Navi Mumbai, India. This role is designed for regulatory professionals with strong expertise in EU post-approval submissions, European regulatory procedures, and CMC lifecycle management.
Teva is a global biopharmaceutical leader with a strong generics and specialty portfolio, committed to delivering high-quality medicines while ensuring full compliance with international regulatory standards.
The Regulatory Affairs Associate II will be responsible for preparing, compiling, reviewing, and submitting high-quality EU post-approval variations and lifecycle management submissions in accordance with European legislation and internal regulatory standards.
This role requires hands-on experience with:
EU Regulatory Procedures (MRP, DCP, CP)
Post-Approval Variations & Renewals
Marketing Authorisation (MA) Compliance
CMC Regulatory Documentation
Change Control & Lifecycle Management
Prepare and submit regulatory dossiers for post-approval activities in compliance with EU legislation.
Manage variations, renewals, and other lifecycle maintenance submissions for allocated products.
Ensure Marketing Authorisations remain compliant with evolving EU regulatory requirements.
Maintain submission timelines and monitor procedural milestones.
Support development and implementation of regulatory strategies for assigned products and projects.
Provide regulatory guidance to cross-functional project teams and European business units.
Monitor regulatory legislation and ensure timely implementation of new requirements.
Maintain awareness of evolving European Medicines Agency (EMA) and member state regulations.
Coordinate with European regulatory authorities regarding pending and proposed submissions.
Communicate submission progress and regulatory updates to stakeholders.
Collaborate with internal departments including QA, CMC, Supply Chain, and Pharmacovigilance to ensure submission accuracy.
Support defined regulatory processes and contribute to continuous improvement initiatives.
Maintain accurate documentation and regulatory tracking systems.
Ensure compliance with in-house regulatory standards and global best practices.
4 to 6 years of Regulatory Affairs experience, specifically in EU post-approval submissions.
4 to 6 years of overall pharmaceutical industry experience.
Demonstrated experience with European regulatory procedures:
Mutual Recognition Procedure (MRP)
Decentralised Procedure (DCP)
Centralised Procedure (CP)
Experience with CMC documentation and change control processes is required.
EU member state regulatory exposure is highly desirable.
Master’s degree in Pharmacy (M.Pharm) or
Master’s degree in Science / Life Sciences
Strong knowledge of EU regulatory legislation and guidelines.
Hands-on experience in CMC regulatory documentation.
Understanding of pharmaceutical lifecycle management and post-approval variations.
Familiarity with internal pharmaceutical company processes and cross-functional coordination.
Proficiency in Microsoft Office applications and regulatory tracking systems.
Excellent written and verbal communication skills in English.
Strong analytical skills for data and documentation review.
Ability to manage multiple submissions under strict regulatory timelines.
Strong organizational and time management capabilities.
Ability to work independently and collaboratively across global teams.
Negotiation and stakeholder management skills.
High attention to detail and regulatory accuracy.
Office-based role in Navi Mumbai, India.
Global exposure to European regulatory authorities and cross-border procedures.
Opportunity to work on complex EU lifecycle management projects.
Collaborative, compliance-driven pharmaceutical environment.
This role provides advanced exposure to:
European Medicines Agency (EMA) Procedures
EU Post-Approval Regulatory Strategy
Global CMC Regulatory Submissions
Lifecycle Management & Regulatory Compliance
Potential progression pathways include:
Senior Regulatory Affairs Associate
Regulatory Affairs Specialist – EU
Regulatory Affairs Manager
Global Regulatory Strategy Lead
Teva Pharmaceuticals is a global leader in generics and specialty medicines, committed to improving patient access to quality healthcare worldwide. The company fosters a collaborative and inclusive culture that supports professional development and innovation.
If you are a Regulatory Affairs professional with 4–6 years of EU post-approval experience, this opportunity in Navi Mumbai offers exposure to European regulatory procedures and global lifecycle management strategy.
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