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Associate Director (CMC Regulatory Affairs) na Amicustherapeutics

Amicustherapeutics · Princeton, Estados Unidos Da América · Hybrid

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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 CMC regulatory activities for commercial phase complex large molecule projects and small molecule projects where required. The candidate will work closely with cross-functional subject matter experts in Technical Operations (Tech Ops), Science, Quality and Global Regulatory Affairs to ensure timely delivery of regulatory deliverables. The candidate will be the liaison between Amicus and any 3rd party involved in managing deliverables and ensuring seamless communication. The candidate will ensure all CMC regulatory submissions (such as pre-submission consultation packages, review of reports and protocols and 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 Module 1, 2 and 3 CMC related sections in regulatory submission with an ability to work collaboratively across cross-functional teams globally. This position also requires taking on accountability to manage agency expectations whilst managing other submission activities. 


Roles and Responsiblities
  • 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.
  • Prepare submission package for Emerging Markets (one CTD for all markets).
  • Support in building best practices and developing work instructions where required.
  • Support in developing work packages when gaps identified.
  • Managing Marketing Specific Requirements for Emerging Markets.
  • Life-cycle maintenance of biologic product in EU, UK, Canada an US.
  • Prepare regulatory strategic to support regulatory submissions both pre and post approval globally.
  • The incumbent will participate, prepare and execute the CMC regulatory strategy or technology transfer of a large molecule.


    • Educational Requirements
  • Minimum Bachelor's degree (M.S. or Ph.D. preferred) in a biopharma discipline.
  • Regulatory Certification (e.g. RAC) preferred.


    • Professional Work Experience Requirements
  • 7 - 10 years' experience in CMC product development, regulatory
  • Experience in managing complex large molecule submissions.
  • Experience working with the FDA.
  • Experience working with other Health Authorities such as EMA, MHRA, SwissMedic, PMDA, Health Canada etc. preferred.
  • Experience managing regulatory activities for biological products (e.g. variations, post-approval filings/commitments, annual reporting etc.).
  • Preferred additional experience managing regulatory activites for non-biological (i.e. small molecule) products.


    • Experience and Skills
  • Experience with CMC regulatory submissions with strong knowledge of Phase III and commercial licensure for complex large molecules.
  • Knowledge and/or experience of CMC regulatory submissions for small molecules preferred.
  • Knowledge of FDA, EMA and global regulations including ICH guidelines with a strong knowledge of eCTD elements, content requirements and structure.
  • Knowledge of and experience with Health Authority interactions.
  • Excellent verbal/written communication and listening skills.
  • Proven planning and organizational skills and regulatory writing skills.
  • Able to collaborate with and lead cross-functional team discussions to support deliverables.
  • Ability to prioritize and handle multiple CMC regulatory deliverables in a dynamic environment.
  • Experience in IND, IMPDs and supporting documentation (i.e. briefing documents). 


    • Other Skills/Attributes
  • Demonstrated alignment with Amicus Mission Focus Behaviors.
  • Passion for rare disease and patient focused


    • Travel
  • Yes. As needed, not on a regular basis.


    • We value an inclusive environment where individual experiences and perspectives are celebrated, and voices from the rare disease community are heard.
     
    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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