Assistant Manager/Manager - Regulatory Affairs - Pharma

Position : Asst. Manager / Manager Regulatory Affairs

Reports to : Head Regulatory Affairs

Working days : Five

Job Location : Baroda (Gujarat)

Qualification : B.Pharm / M.Pharm / M.Sc. Chem/PG

Purpose of the role :

Responsible for maintaining the Drug Regulatory compliances as per USFDA, Indian Drug Authorities and to obtain all relevant permissions from agencies by filing the dossier and Liasioning with them for Pharma products.

Job Description :

- Responsible for DMF Management : Manage Drug Master File and other regulatory data required for manufacturing and marketing permissions and liasioning with the agencies.

- Indian Drug Permissions/License : To obtain the necessary Licenses / Permissions from Indian Drug Authorities as per Drugs & Cosmetic Act required for manufacturing and marketing permissions and liasioning with the agencies.

- Effectively plan and manage the External Regulatory Audit with Internal and External stakeholders. Review and Coordinate the effectiveness of CAPA and submit to agencies. Perform GAP analysis or baseline assessment at site adhering to cGMP norms.

- Perform due diligence and Coordinate in preparation of different types of regulatory submissions (e.g. dossier, variations, scientific advice submissions, CAPA) to competent authorities worldwide for approved and developmental products and to Operate Electronic Submission efficiently.

- Review of Regulatory requirement for different countries (For Regulated / Non- Regulated Market) and develop content, time-lines and contingencies for submissions in collaboration with internal and external contributors