About the Role
Seeking an experienced Manager – Regulatory Affairs to lead regulatory strategy, submissions, and compliance for our product portfolio. The ideal candidate will have strong knowledge of Indian and global regulatory frameworks and proven experience in managing dossiers, approvals, and compliance with authorities like CDSCO, FDA, DCGI, and FSSAI.
Key Responsibilities
- Develop and implement regulatory strategies for new and existing products.
- Prepare, review, and file dossiers, NDAs, notifications, and submissions with regulatory bodies.
- Ensure ongoing compliance with GMP, GCP, labeling, and advertising standards.
- Maintain and update regulatory documentation (technical files, safety dossiers, product registrations).
- Liaise with regulatory authorities (CDSCO, State FDA, DCGI, port offices) for approvals and queries.
- Collaborate cross-functionally with R&D, QA, Marketing, and Legal teams to ensure compliance throughout the product lifecycle.
- Lead regulatory support for audits, inspections, and certifications.
- Monitor global regulatory updates (FSSAI, FDA, EU, ASEAN, GCC, NAFDAC) and assess impact on the business.
- Oversee post-market regulatory management including change control, reporting, and recalls.
Qualifications
- Bachelor's / Master's degree in Pharma, Regulatory Affairs, Food Science, Chemistry, or Life Sciences.
- 5–10 years experience in Regulatory Affairs (Pharma, Nutraceuticals, Food, or Healthcare).
- Strong knowledge of Indian & international regulations (FSSAI, FDA, DSHEA, FSMA, EU).
- Experience in product submissions, NDAs, compliance audits, and dossier management.
- Excellent analytical, communication, and project management skills.
