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
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.