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CMC Combination Products Regulatory Affairs Lead

2 months ago

Harlow, Essex, United Kingdom Teva Pharmaceuticals Full time
About the Role

We 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 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.
Requirements
  • 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.
What We Offer
  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive compensation and benefits package.