Job Description

Key Responsibilities:
Lead and support global regulatory activities for device constituent parts of biosimilar combination products, including submissions, lifecycle management, and compliance.
Author, review, and coordinate device-related sections for BLA, IND, MAA, MDR, CE Marking, and post-approval regulatory submissions.
Prepare and manage responses to regulatory authority queries, information requests, and audit observations.
Review technical documentation, change controls, deviations, CAPAs, and other QMS-related records for medical devices.
Ensure compliance with applicable regulations, standards, and internal procedures, including support for ISO 13485, MDR, and regulatory audits.
Collaborate with cross-functional teams, partners, and regulatory authorities to support product development, registration, and lifecycle management activities.




Monitor evolving global device regulations and drive implementation of applicable regulatory requirements.
Support training, knowledge sharing, and continuous improvement initiatives within the organization.

Preferred Experience:
Bachelor's or Master's degree in Life Sciences, Pharmacy, Biomedical Engineering.
10–14 years of experience in Regulatory Affairs within the pharmaceutical, medical device, or drug-device combination product industry.
Solid Knowledge of FDA (BLA/IND), EU MDR, CE Marking, ISO 13485, and global regulatory requirements.
Experience in technical dossier review, regulatory submissions, and post-approval change management.
Robust cross-functional collaboration and stakeholder management skills.

📌 Associate Manager Bengaluru
🏢 Biocon
📍 Bengaluru