Associate Manager

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. - Strong 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.