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.

- Strong cross-functional collaboration and stakeholder management skills.

📌 Associate Manager (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru