Assistant Manager, Regulatory Affairs

About the role

Preparation, scientific review, coordination & finalization of ANDA/NDA CMC modules for oral solid, oral liquid, injectable & other dosage form as per the business goals. Preparation of project status, discussion slides & white papers as required for escalation & decision at different stages of the projects.

What you'll do

• Working on due diligence projects for US, EU & Canada markets as per the business agreement
• Managing pre-approval portfolio including original submission, deficiency response, final approval request & any other submissions
• Provide support in developing/updating regulatory tools, checklists, databases as per dept. needs
• Participate in project meetings, communication & coordination with CFTs

What you need

• 8–12 yrs of experience
• Regulatory affairs
• Due diligence
• Communication
• M.Pharm

Good to have

• Technical writing