Regulatory Affairs Post-Approval Manager (Europe) - DEMO Global Services Center

At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Post-Approval Manager to join our team. The candidate will be responsible for managing variations, life-cycle management, and compliance for authorised products for sterile, non-sterile and oral solid/liquid products for Europe and global markets etc.

This role involves close collaboration with cross-functional teams (e.g. R&D, Quality, Clinical, Country RA teams and business partners). This position is based at Hyderabad, India.

Responsibilities:

• Oversee the planning, authoring, coordination, and submission of European variations including renewals, extensions and responding health authorities for marketing authorisation applications.
• Regulatory Strategy: Evaluation of change proposals and providing the regulatory strategy for assigned regulatory projects for sterile (small volume parenteral, large volume parenteral, lyophilized product, sterile powder, infusion bag etc.), non-sterile and oral solid/liquid products.
• Gap analysis of approved marketing authorisation for new regulatory requirements for quality and labeling updates required and submission of variations according to the predefined priorities.
• Managing the responses to deficiency letters and other CMC-related regulatory queries.
• Cross-functional Collaboration: Working closely with global teams across R&D, manufacturing, quality, labelling and collection of the documents for preparation of post-approval submissions.
• Maintain dossiers and ensure ongoing compliance with EU post-marketing requirements. Staying up-to-date with regulatory guidelines, and interpreting regulations to ensure compliance.
• Identify and escalate the risks associated with regulatory submissions and projects to superiors.

Requirements:
• Master or Bachelor degree in Pharmacy.
• 13+ years in Regulatory Affairs, with at least 9 years focused on EU post-approval activities, including variations and lifecycle management. Post-approval activities experience for Australia and/or Canada is a strong advantage.
• Thorough understanding of European medicinal product regulation and procedures, EMA & CMDh guidance, and EU GMP guidelines.
• Sound understanding of Sterile and Oral solid/liquid dosage form.
• Ability to influence cross-functionally and negotiate with regulators.
• Skilled in managing multiple priorities effectively within fast‑paced environments.

Benefits:
The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.