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Senior/Director Regulatory CMC (Combination Product)

United States

Role

  • Develop strategies addressing both biologic/drug and device components and align with company goals and regulatory expectations.
  • Comprehend regulations, regulatory standards, directives, guidelines and advise Development, Technical Operations, and Quality teams on their applicability to and impact on product development projects.
  • Lead plans and protocols for compatibility, design verification and functional stability studies, as well as  contribute to the design of human factor studies and usability testing.
  • Provide strategic input to Design Control processes and documentation, ensuring alignment with health authorities and notified body requirements and global technical standards. Review DHF documentation from a regulatory perspective.
  • Design and execute submission strategies for device-related dossier components (INDs/CTAs, marketing applications, and post-approval changes) in collaboration with company SMEs.
  • Conduct research for the development of state-of-the-art studies.
  • Operating effectively in a matrixed environment, influence cross-functional decision-making without direct authority.
  • Assess change controls to identify and mitigate any regulatory risks.
  • Lead health authorities and notified body interactions.
  • Oversee device-related regulatory information in company systems.
  • Support other Regulatory CMC activities.

 

Requirements

  • Experience as the regulatory lead for combination products in pharmaceutical, biotechnology, or medical device industry setting.
  • Prior and proven experience in late stage development of combination products.
  • In-depth and broad experience with regulations, standards, directives, guidelines and requirements related to the use of combination products in global clinical trials and commercial registration.
  • Strong understanding of ISO and ASTM standards relevant to combination products.
  • Up to date with current industry trends and regulatory expectations associated with combination products.
  • Good knowledge of ICH guidelines and GMP requirements for the development and manufacturing of biologics.
  • A successful candidate will have strong communication skills, strategic acumen, collaboration, and influencing attributes.
  • A bachelor's degree preferably in a scientific/engineering discipline
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Discipline

Biotech

Job Ref

PR/030108

Published

23 days ago

Expiry

26 Apr 2026 23:59

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