Job Description

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 execution of post-marketing regulatory activities for MENA region, CIS, Asia-Pacific and others global markets.

This role involves ensuring continuous product compliance, managing post-market submissions, and providing strategic regulatory guidance across these diverse and evolving markets. The manager acts as the primary liaison between the company and health authorities/business partners in the applicable regions. This position is based at Hyderabad, India.

Responsibilities:

• Oversee the planning, authoring, coordination, and submission of post-approval variations 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 & large volume parenteral, aqueous solution, 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.
• Regulatory Compliance: Monitor and interpret changes in local legislation, guidelines, and industry trends across the MENA, CIS, and Asia-Pacific regions etc., translating these into actionable steps for the organization to ensure ongoing compliance.
• Identify and escalate the risks associated with regulatory submissions and projects to superiors.

Requirements

• Master or Bachelor degree in Pharmacy.
• 12+ years in regulatory affairs, with at least 8 years on post-approval activities, including variations and lifecycle management for MENA region, CIS, Asia-Pacific and others global markets.
• Sound understanding of Sterile and Oral solid/liquid dosage form.
• Thorough knowledge of post-marketing regulatory submissions across global market.
• Ability to influence cross-functionally and negotiate with regulators.
• Strong project management skills for coordinating and balancing multiple priorities.

Benefits

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