Manager - Regulatory Affairs - Pharma

Regulatory Affairs Manager - IMEA (Multinational company) (15-20 yrs)

- Provide leadership for the Regulatory Affairs

- Responsible for planning and implementing global policies, practices and strategy for the regulator functions.

- This position leads all departmental planning, manages multiple project teams and provides the regulator strategies to ensure appropriate implementation of key business initiatives.

- The position acts as the primary liaison with the global regulatory agencies with responsibility for global regulatory submissions. The position provides the Regulatory Department interface to executive management and is seen as one of the top leaders to fully support the leadership team in implementing strategic corporate decisions.

- Interacts with other functions at all levels of the organization including corporate officers, group, area coordination team and GBU pharma functions.

- As a Regulatory Affairs Manager, the accountability encompasses meeting complete Regulator Affairs'people, process & profitability.

Profile :

- Masters Doctoral degree in a technical discipline especially in pharmacy or medicine.

- Qualified Medical Doctors who are practicing Regulatory Affairs will also be considered. Certification in Regulatory Affairs will be preferred.

- Excellent knowledge of working with Regulatory bodies like FDA (US), TPD (Canada), EMEA (European Union), Ministry of Health (India) and other relevant bodies.