- Prepare and submit regulatory dossiers, reports, and documents to relevant authorities for product registration and approval.
- Ensure compliance with regulatory requirements, guidelines, and timelines throughout the product lifecycle.
- Collaborate with cross-functional teams to develop strategies for successful product launches in India.
- Provide guidance on regulatory affairs matters to internal stakeholders. Job
Requirements:
- 3-8 years of experience in Regulatory Affairs or related field (Pharmaceutical industry).
- Solid understanding of CMC (Chemistry Manufacturing Controls) regulations and dossier preparation.
- Experience working with Indian regulatory bodies such as CDSCO, DGMS, FSSAI etc.