REGULATORY AFFAIRS MANAGER @ STIVAPH HEALTHCARE PVT LTD
STIVAPH HEALTHCARE PVT LTD, based in India, is urgently seeking a highly experienced and dedicated Regulatory Affairs Manager to join our dynamic team. This critical role is centered around managing the regulatory landscapes of our crucial Emerging Markets, specifically across Asia and Africa. The ideal candidate will be instrumental in securing and maintaining product registrations, ensuring that all pharmaceutical formulations comply with the highest standards set by various international regulatory bodies. This position is vital for driving the company's export and international business development success in key territories.
The position is based in India, with primary work locations being Ahmedabad and Sanand. The Regulatory Affairs Manager will utilize their expertise to navigate complex regulatory frameworks covering countries such as the Philippines, Myanmar, Kenya, Nigeria, Ghana, Tanzania, and Zimbabwe. Candidates must possess a strong background in pharmaceutical regulation, demonstrating both strategic insight and operational excellence. We are looking for a professional who can handle the entire lifecycle of regulatory submissions, ensuring timely and effective market access for our products across these high-growth regions.
The position is based in India, with primary work locations being Ahmedabad and Sanand. The Regulatory Affairs Manager will utilize their expertise to navigate complex regulatory frameworks covering countries such as the Philippines, Myanmar, Kenya, Nigeria, Ghana, Tanzania, and Zimbabwe. Candidates must possess a strong background in pharmaceutical regulation, demonstrating both strategic insight and operational excellence. We are looking for a professional who can handle the entire lifecycle of regulatory submissions, ensuring timely and effective market access for our products across these high-growth regions.
Key Requirements
Minimum 8 to 12 years of relevant experience in Regulatory Affairs within the pharmaceutical industry.
Mandatory qualification of M.Pharm (Master of Pharmacy).
Profound knowledge of regulatory affairs processes specific to Emerging Markets (Asia & Africa).
Experience managing regulatory submissions, variations, and renewals for international markets.
Ability to ensure continuous compliance with diverse regional regulations in countries like the Philippines, Myanmar, Kenya, Nigeria, Ghana, Tanzania, and Zimbabwe.
Proven track record in developing and executing global regulatory strategies.
Excellent documentation skills for preparing and maintaining regulatory dossiers.
Strong understanding of formulation development processes relevant to regulatory submissions.
Exceptional communication and stakeholder management skills.
Demonstrated capability to work effectively in a high-pressure, export-focused environment.