Vacancy for Regulatory Affiars Head at Abbott Pharmaceuticals | Apply Now

Abbott Pharmaceuticals - Pharmawalks

Greetings from Abbott Pharmaceuticas..!!!
We are hiring following positions. Please find the details attached below

POST NAME: HEAD REGULATORY AFFAIRS
Qualification: M.Sc / B.Pharm / M.Pharm / Ph.D in Pharmacy having relevant experience of around 14 – 16 years in regulatory affairs mainly for emerging markets. Having exposure to US / EU will be an added advantage
Location: Mumbai
MAIN PURPOSE OF THIS ROLE :

  • Manages teams within the Regulatory Affairs Sub-Function.
  • Focus is on policy and strategy implementation and control rather than development.
  • Typically handles short-term operational/tactical responsibilities.

MAIN RESPONSIBILITIES :

  • As the Manager of the Regulatory Affairs Sub-Function, oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
  • Interacts with regulatory agency to expedite approval of pending registration.
  • Serves as regulatory liaison throughout product lifecycle.
  • Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
  • Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
  • Serves as regulatory representative to marketing, research teams and regulatory agencies.
  • Advises development and/or marketing teams on manufacturing changes, line extensions, technical labelling, appropriate regulations and interpretations.

Apply Online>>

About the author

Leave a Reply