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    Associate Director - United Kingdom - RPMGlobal

    RPMGlobal
    RPMGlobal United Kingdom

    6 days ago

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    Description

    Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.

    The Chemistry, Manufacturing and Controls (CMC) Regulatory team at Amicus is looking for a seasoned CMC candidate responsible for leading Chemistry, Manufacturing and Controls (CMC) regulatory activities for commercial phase large molecule project.

    The candidate will work closely with cross-functional subject matter experts in Tech Ops, Science, Quality and Global Regulatory Affairs to ensure timely delivery of regulatory deliverables.

    The candidate will ensure all CMC regulatory submissions (such as pre-submission consultation package, review of reports and protocols & preparation of variations) are of the highest quality and delivered on time keeping patients in the forefront of how we work.

    This position requires strong written and verbal communication skills, knowledge and experience in regulatory writing and preparation of CMC sections in regulatory submission with an ability to work collaboratively across cross-functional teams across geographies.

    Drive the preparation and submission of high-quality CMC submission packages for large molecules (Briefing documents, scientific advice, variations etc)

    • Deliver CMC regulatory content for submissions by engaging with CMC Tech Ops and Quality teams
    • Liaison between Manufacturing sites, Global Regulatory Affairs, Technical Operations, Science and Quality Assurance
    • Ensure CMC development strategies are aligned with global regulatory expectations
    • Support in building best practices and developing work instructions where required
    • The incumbent will participate, prepare & execute the CMC regulatory strategy for technology transfer of a large molecule.
    Minimum Bachelor's degree (M.Regulatory Certification (e.g. Professional Work Experience Requirements

    • 7-10 years' experience in CMC product development, regulatory
    • Experience managing biological product for all regulatory activities
    Experience with CMC regulatory submissions with strong knowledge of Phase III and commercial licensure for large molecules

    • Proven planning and organizational skills and regulatory writing skills
    • Ability to prioritise and handle multiple CMC regulatory deliverables in a dynamic environment
    • Travel
    • Some travel might be required

    We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

    Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence.

    Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.

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