Job Title: Specialist Regulatory Affairs LCM- Growth Products
Location: Andheri, Mumbai (Hybrid working)

About the Role
As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we are seeking a Specialist Regulatory Affairs – LCM Strategic Growth Products to join our Regulatory team.
To perform life cycle maintenance activities for the Marketing Authorizations (MA) held by ADVANZ PHARMA for the Strategic Growth Products, with a focus on keeping MA up-to-date and ensuring supply continuity and compliance.
Strategic Growth Products will include Innovative Medicines (NCEs or Biologics), Biosimilars, and Specialty Generics that will require significant technical input on the CMC and Clinical sides during the post-approval phase.
While the post approval responsibilities of Biosimilars would sit with this role through the life cycle of the product,



there will be a transition of responsibilities for Innovative Medicines and Specialty Generic products following completion of post approval commitments (Clinical or CMC/Manufacturing in nature) to the LCM Established Products team.
What You'll Be Responsible For

Support Current Product Introduction (NPI) activities, including label/mock-up approvals, translations, and management of national phase procedures for DCPs.
Serve as the primary Regulatory contact for Health Authorities and internal stakeholders following Marketing Authorisation approval.
Partner closely with the NPI Product Lead to gain expertise in MA procedures, Health Authority interactions, key commitments, and post-approval requirements supporting launch and supply continuity.
Lead post-approval regulatory activities in collaboration with cross-functional teams, including renewals, variations, maintenance activities, regulatory commitments, shortage notifications, PIP compliance, orphan designation maintenance, and labeling updates.
Act as Global LCM Product Lead for assigned molecules (pri

📌 Specialist Regulatory Affairs LCM (Mumbai)
🏢 AdvanzPharma
📍 Mumbai