Regulatory CMC Manager, Cell and Gene Therapy

Location

Europe

Posted

1 day ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglish

Job Description

Regulatory CMC Manager, Cell and Gene Therapy

Syneos Health

• Support the execution of cell and gene therapy global regulatory CMC strategies for marketed and development products • Contributes to the preparation and submission of regulatory CMC documentation • Provides regulatory support and guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs • Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies • Contributes to the development of global regulatory CMC strategies for commercial products • Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions • Provides regulatory CMC guidance to cross-functional teams and key stakeholders • Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

Job Requirements

  • Strong interpersonal skills to exchange complex information with others and to guide others
  • Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
  • Experience in the preparation, including writing, of CMC submissions
  • Strategic thinking and strong problem solving skills
  • Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
  • Strong sense of planning and prioritization, and the ability to work with all levels of management
  • Capable of strategic thinking with ability to resolve complex and ambiguous situations
  • Sound knowledge of cGMP, FDA, EMA, ICH
  • Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field

Benefits

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to building an inclusive culture – where you can authentically be yourself.

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