Regulatory Affairs Manager

Company Description

Wockhardt Ltd. is a global pharmaceutical and biotechnology organization committed to providing affordable, high-quality medicines. Headquartered in Mumbai, India, Wockhardt has a multi-ethnic workforce of 3000 associates across 21 nationalities. The company operates 3 research centers and 12 manufacturing plants, with a strong presence in the USA, UK, Ireland, and France. Wockhardt focuses on innovation, using science and technology to develop medicines and products that enhance the quality of life for millions worldwide.

Position: Manager / Asst. Manager - Regulatory Affairs

Location: Chhatrapati Sambhajinagar (Aurangabad), Maharashtra

Qualifications: Master's degree in Pharmacy, Life Sciences, or related field

Experience: 8-12 years experience in Regulatory Affairs in Emerging Market filings

Role Description

This is a full-time, on-site role for a Regulatory Affairs Manager located at Chhatrapati Sambhajinagar (Aurangabad) Maharashtra. This position will be responsible for ensuring regulatory compliance, preparing and submitting regulatory documents, and maintaining quality systems. The role requires close collaboration with cross-functional teams to meet regulatory requirements and ensure the successful registration and approval of pharmaceutical products.

Desired :

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 authoritiesin 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