Regulatory Affairs Director for Combination Products and Devices
5 days ago
We are seeking a highly experienced and skilled Director, Regulatory Affairs CMC Combination Products to join our Global Regulatory Affairs, CMC Biologics, Devices department at Teva Pharmaceuticals.
Key Responsibilities- Provide global regulatory CMC strategy and guidance for combination products, platform devices, and assigned marketed products, as well as those assigned products that are currently in development.
- Support the development and communication of effective device and combination product platform-related regulatory strategies for development and post-marketing submission activities.
- Collaborate with cross-functional teams, including Digital Health, Commercial, Quality, and Combination Product development teams.
- Coordinate, support, author, and/or review device platform-specific agency interactions and assist in the submission of regulatory correspondence to agencies.
- Assist in planning and conducting meetings with regulatory agencies and Notified Bodies to support device-related activities.
- Review device-specific regulatory documents, including development reports, validation protocols, standard operating procedures, test methods, specifications, protocols, and reports.
- Support the Global Regulatory Affairs (GRA) CMC team for the global initiative for marketed products and assist with the preparation of complete registration dossiers to be submitted to health authorities.
- Ensure global consistent change management and compliance of regulatory commitments.
- Keep oversight of global device-related regulations and provide consolidated training and consultancy to Subject Matter Experts (SMEs) and GRA.
- Organize and share knowledge associated with medical devices.
- Support GRA functions with and keep central track/documentation of authority requests, e.g., Notified Body Opinion, Commitments, categorization of products.
- Ensure adequate change control and complaints management for devices/device components from a global RA perspective in collaboration with Quality Assurance (QA) and Pharmacovigilance (PV).
- Ensure adequate and efficient processes to obtain device-specific documentation.
- Leverage synergies and harmonization across business units, functions, and roles within GRA, including establishing overarching work instructions/business practices.
- Represent Teva at industry associations and conferences.
- The Device Regulatory Affairs CMC Director is also responsible for maintaining and updating internal platform device strategy documents and device-relevant sections of submissions for Teva products.
- Identify, propose, and implement improvements and simplification of processes in connection with other relevant functions and key stakeholders.
- Advocate for harmonization in processes across the organization.
- Participate in Quality/Regulatory governance meetings for managerial oversight of device compliance and change management.
- Monitor regulatory compliance using applicable metrics and KPIs.
- Bachelor's degree in a scientific discipline (must have). Advanced degree (M.Sci., Ph.D., PharmD) is preferred.
- Strong pharmaceutical and/or device industry experience (must have).
- Relevant technical experience in combination products, digital health products, analytical (QC, analytical R&D), process/product development, or manufacturing is preferred.
- Management experience in Regulatory Affairs.
- Knowledge of ISO, US, EU, and ICH regulatory guidelines.
- Experience with eCTD regulatory filings.
- Knowledge of US and global content and regional requirements.
- Knowledgeable in drug development processes and life cycle management of products.
- Clear, concise technical writing skills.
- Good interpersonal, communication, and organizational skills.
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- A competitive compensation and benefits package.
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Harlow, Essex, United Kingdom Teva Pharmaceuticals Full timeAbout the RoleWe are seeking a highly skilled and experienced Director, Regulatory Affairs CMC Combination Products to join our Global Regulatory Affairs, CMC Biologics, Devices department at Teva Pharmaceuticals.Key ResponsibilitiesProvide global regulatory CMC strategy and guidance for combination products, platform devices, and assigned marketed products,...
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Harlow, Essex, United Kingdom Teva Pharmaceuticals Full timeAbout the RoleWe are seeking a highly skilled and experienced Director, Regulatory Affairs CMC Combination Products to join our Global Regulatory Affairs, CMC Biologics, Devices department at Teva Pharmaceuticals.Key ResponsibilitiesProvide global regulatory CMC strategy and guidance for combination products, platform devices, and assigned marketed products,...
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