Sun Pharma is the fourth-largest specialty generic pharmaceutical company globally and India’s top pharmaceutical company. With a presence in over 100 countries, we are committed to delivering high-quality, affordable medicines to improve healthcare worldwide. Our R&D center in Tandalja is a hub for innovation, focusing on complex generics, specialty products, and novel drug delivery systems.
Job Description
We are seeking an experienced Regulatory Affairs Executive to join our team in Tandalja (R&D). The ideal candidate will have expertise in Non-Oral dosage forms (injectables, topicals, ophthalmics, etc.) and a strong background in global regulatory submissions.
Key Responsibilities:
- Review and compile regulatory documents for product registrations in US, Canada, Europe, Australia, and China.
- Prepare and submit registration dossiers (eCTD, CTD, ACTD) to health authorities.
- Respond to deficiency letters from regulatory agencies (FDA, EMA, TGA, etc.).
- Manage post-approval changes and lifecycle maintenance of drug products.
- Provide regulatory support to cross-functional teams (R&D, QA, Production).
- Prepare scientific advice queries for health authorities.
- eCTD compilation, verification, and submission via electronic gateways.
Preferred Qualifications:
- Experience in Non-Oral products (injectables, topicals, inhalers, etc.) is a plus.
- Strong knowledge of ICH guidelines, GMP, and regulatory requirements.
- Proficiency in eCTD tools (DocuBridge, Lorenz, etc.).
- Excellent communication and analytical skills.
