Regulatory Affairs Associate – Hybrid (Mumbai/Vadodara)

About the role

We are looking for a Regulatory Affairs Associate to join our Global Regulatory Affairs team. The role supports product labeling, lifecycle management and regulatory submissions for a diverse international portfolio, working in a hybrid model from Mumbai or Vadodara.

Key responsibilities

• Develop, maintain and implement global product labeling strategies, including CCDS, SmPCs, package inserts and patient information documents.
• Prepare, review and update global and regional product information to ensure regulatory compliance.
• Manage labeling updates and lifecycle activities across multiple markets (Europe, North America, Australia, emerging markets).
• Prepare regulatory documentation for product information variations, updates and submissions.
• Contribute to Labelling Committee activities, including preparation, review and presentation of supporting documents.
• Maintain accurate product information records in regulatory information management systems (RIMS) and electronic document management systems (eDMS).

Required profile

• Experience in product labeling, lifecycle management and global regulatory processes.
• Ability to work collaboratively with Regulatory Affairs, Pharmacovigilance, Artwork, Supply Chain and external partners.
• Strong attention to detail and ability to manage multiple regulatory projects.

Required skills

• Product labeling
• Lifecycle management
• Global regulatory processes
• Regulatory information management systems (RIMS)
• Electronic document management systems (eDMS)