Regulatory Affairs Associate (GPR & Reg Ops)

Job description
- CTD Dossier Drafting (Modules 2, 3, 4)

- Regulatory writing

- Clinical Regulatory Pharmacovigilance Regulatory

- Preparation of Tox applications, CTAs, MAAs

- Regulatory commitment compliance

- Any other Regulatory activities on need basis

- Support Line manager Matrix manager in Regulatory projects

- Coordination and interaction with cross-functional teams

Role: Regulatory Affairs Compliance
Industry Type: Pharmaceutical & Life Sciences
Department: Legal & Regulatory
Employment Type: Full Time, Permanent
Role Category: Corporate Affairs
Education
UG: Any Graduate
PG: Any Postgraduate
Key Skills
Regulatory Affairs AssociateMatrixComplianceAnalyticalPharmacovigilance