Regulatory Affairs Post-Approval Manager - DEMO Global Services Center

Demo S.A.

  • Hyderabad, Telangana
  • Permanent
  • Full-time
  • 3 days ago
  • Apply easily
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.
BenefitsThe company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.

Demo S.A.