Regulatory Affairs Specialist

Lead end-to-end regulatory activities for Emerging and Regulated Markets, including submissions, approvals, and post-approval changes.

Encompassing pre- and post-approval phases such as initial submissions, query responses, variations, renewals, and ongoing post approval maintenance.

The role demands strong expertise in global regulatory requirements, dossier preparation, and Health Authority interactions.

Develop and implement robust regulatory strategies for new product registrations, life cycle management, and market expansion plans in alignment with global business goals.

Ensure all regulatory documentation is accurately maintained, audit-ready, and aligned with internal SOPs and external audit requirements.

Strategically plan, manage, and supervise the preparation, compilation, and timely submission of high-quality regulatory dossiers, ensuring full compliance with country-specific and international regulatory requirements.

Minimum 10 years of progressive experience in Regulatory Affairs within the pharmaceutical industry, with demonstrated success in handling regulatory responsibilities for both Emerging and Regulated Markets (e.g., US, EU, ROW, LATAM, Asia-Pacific).

Proven expertise in regulatory dossier preparation (CTD/eCTD format), submission strategy, and Health Authority engagement.

Strong leadership, decision-making, and cross-functional collaboration skills.

Excellent understanding of global regulatory guidelines (ICH, WHO, USFDA, EMA, etc.)