Experience: 8-12 years experience in Regulatory Affairs (Emerging Market filings)
Requirements :
1. Experience in authoring CMC sections of dossier for drug substance and drug product
2. Experience in – handling applications including regional modules and queries from various health authorities in emerging markets (Asia/Africa/MENA/LATAM)
3. Well versed with ACTD/eCTD formats of applications, change control and life cycle management
4. In-depth understanding of clinical and non-clinical module
Wockhardt is a global pharmaceutical and biotechnology company committed to delivering affordable, high-quality healthcare solutions to improve lives around the world. As one of India’s top research-driven healthcare enterprises, Wockhardt operates across pharmaceuticals, biotechnology, and a network of cutting-edge Super Speciality Hospitals.
Proudly recognized as a true Indian multinational, Wockhardt employs a diverse team of 8,600 professionals from 21 nationalities, reflecting its global footprint. The company operates three state-of-the-art research centers and twelve manufacturing facilities, producing a wide range of pharmaceutical formulations, biopharmaceuticals, APIs, and vaccines to meet critical health needs worldwide.
