Regulatory Affairs Specialist

- Master and CTD Dossier Drafting Review (Modules 2, 3, 4)

- Preparation of Module 1 documents

- Preparation and Positioning of Country specific dossiers

- CMC, NC Regulatory writing

- Clinical Regulatory Pharmacovigilance Regulatory

- Preparation of Product label content (PIL, SPC, Container-closure labels cartons)

- Preparation and submission of Tox applications, CTAs, MAAs

- Regulatory commitment compliance

- Support Line manager Matrix manager in Regulatory projects; Regulatory representation in project team meetings for inputs, guidance, projects

- Coordination and interaction with cross-functional teams, affilitaes and partners

- Support in Regulatory Intelligence; Regulatory review of various primary documents

- Any other Regulatory activities on need basis