Job description
Roles and Responsibilities :
- Manage regulatory dossiers, including ANDA (Abbreviated New Drug Application) submissions to US FDA.
- Ensure compliance with ECTD (European Common Technical Documentation) guidelines for regulatory submissions.
- Develop and maintain CMC (Chemistry, Manufacturing, and Controls) sections of regulatory documents.
- Collaborate with cross-functional teams to ensure timely submission of high-quality regulatory applications.
Job Requirements :
- Fresher to 2 years of experience in Regulatory Affairs or related field.
- Strong understanding of biosimilars regulations and life cycle management.
- Proficiency in preparing complex regulatory dossiers, including ANDAs and eCTDs.
Pay: ₹10,000.00 - ₹50,000.00 per month
Work Location: In person
