Regulatory Affairs Specialist

Role & responsibilities

- Review, compile and submit the Application dossiers (ANDA, MAA) to regulatory agencies like US-FDA, EMA, Health Canada, Australia and ROW countries.

- Review and approve regulatory CMC documents being generated at R&D and commercial manufacturing facility such as development reports, BMR, BPR, Specifications, method validation reports, process validation reports, stability protocols, stability data etc. and ensure regulatory compliance.

- Maintenance of the complete history of each Drug products (Filing history with agencies/customers, amendments).To coordinate in regulatory audits and provide regulatory support.

- Coordination with internal and external stakeholders for regulatory filing related documentation.

- Communicate the agency's comments/deficiencies to respective in house departments, prepare the response and submit it back to the agency.

- Hands on experience of post approval variations and Annual reports.

Preferred candidate profile

Master of Pharmacy

Perks and benefits

As per Company Standards