Regulatory Strategy: Lead regulatory submissions for new drugs, generics, biologics, or medical devices in India (and sometimes APAC/global markets).
Compliance: Ensure company operations comply with DCGI, CDSCO, ICH, WHO, and other regional/global regulations.
Dossier Preparation: Oversee preparation and review of CTD/eCTD dossiers, IND, NDA, ANDA, variations, labeling, and renewals.
Liaison: Act as the key point of contact with regulatory authorities (DCGI, CDSCO, state FDAs).
Cross-functional Leadership: Work closely with R&D, Quality, Clinical, Medical Affairs, and Manufacturing teams.
Team Management: Guide junior regulatory associates/managers, review their work, and build submission strategies.
Regulatory Intelligence: Monitor regulatory landscape, track policy changes, and advise leadership on impact.
Standard MNC benefits (PF, gratuity, insurance, paid leaves).
Performance bonus & incentives.
Training & development (ICH, global regulatory affairs workshops).
Cross-border exposure (working with global regulatory teams).
Career progression into Regulatory Head / Director roles.
About AstraZeneca India AstraZeneca India comprises two main entities and plays a significant role in the global operations of AstraZeneca: 1. AstraZeneca Pharma India Ltd (AZPIL) Established in 1979 and headquartered in Bengaluru, AZPIL is a... Read More