Assistant Manager - Regulatory Affairs - Pharma

We have urgent opening for one of the Leading Biotechnology Company

Position: Assistant Manager - Pharma Regulatory Affairs. Can consider Manager for exceptional candidates with a proven track record and who can demonstrate long term commitment.

Job location: Shuttle between Factory/Head office in Hyderabad.

Qualification: M.Sc Microbiology/Biochemisty/B Pharm / M. Pharm (Pharmacology/ Pharmaceutics)/ M SC.( Mandatory)

Experience: 5+ years in regulatory affairs in a pharmaceutical industry

Job Description :

Reporting to Executive Director

- To prepare drug dossiers for API and finished products for the ROW/ASEAN market. Must have working knowledge and be able to handle dossier compilation, submission and follow up independently.

- Manage Regulatory Affairs & Pharmacovigilance. To have good knowledge of global and Indian regulatory requirements. To prepare dossiers for registration of new as well as generic Products.

- To give inputs for the preparation and submission of dossiers, MAA (Marketing Authorization Applications) for new drugs. To assure conformity of dossiers to the local statutory requirements.

- To update registration databases for compliance to global and local regulations. To maintain active and effective contacts with Corporate Regulatory Affairs and with colleagues in other Affiliates

- To assist in preparing dossiers for food ingredients/nutraceutical ingredients/ dietary supplements for the entire world. Be able and willing to read regulations and help with interpretations.

- Personality Traits/ Skills - Good command over written and spoken English - An eye for detail.

- Looking for a long term opportunity- An analytical bent of mind. - Self-motivation - Good networking skills / Resourcefulness - Result - orientation - Good scientific background - Computer literacy.