Director, CMC RA

Director, CMC RA

Amicus Therapeutics

Marlow, United Kingdom

Position Summary:

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 development & commercial phase multi-modality projects. 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 be the liaison between Amicus and any 3rd party involved in managing deliverables and ensuring seamless communication. The incumbent will manage, prepare & execute the CMC regulatory strategy for technology transfer of small and large molecule programs. 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. This position also requires taking on accountability to manage agency expectations whilst managing other submission activities. This position requires managing direct reports with expertise in small and/or large molecules.

Roles and Responsibilities:

• Drive the preparation and submission of high-quality CMC submission packages for small & large molecules (Briefing documents, scientific advice, variations etc).
• Deliver CMC regulatory content for submissions by engaging with CMC Tech Ops, GRA and Quality teams.
• Oversee deliverables for small & large molecule submissions such as new MAAs, post-approval variations and any clinical submission.
• Liaison between Manufacturing sites, Global Regulatory Affairs, Technical Operations, Science and Quality Assurance.
• Ensure CMC development strategies are aligned with global regulatory expectations. Review and implement current and emerging global regulatory requirements for commercial products
• Life-cycle maintenance of products in EU, UK, Canada and US
• Manage a high performing team of a small group of direct reports including permanent and contract worker.

Requirements:

Educational Requirements:

• The successful candidate must possess a BS degree in Pharmacy, Biology, Chemistry or related healthcare functional area. MS or PhD preferred.
• Regulatory Certification (e.g. RAC)

Professional Work Experience Requirements:

• 10+ years’ experience in CMC product development, regulatory.
• Experience in managing complex large molecule submissions and experience in managing small molecules submissions.
• Experience working with Health Authorities such as EMA, MHRA, FDA, SwissMedic, PMDA, Health Canada.
• Experience with CMC regulatory submissions with a thorough understanding of current U.S. and global pharmaceutical regulatory requirements pertaining to CMC sections of regulatory filings is required
• Experience in managing and developing direct reports

Experience and Skills:

• The candidate must have a solid understanding of development of innovative products under standard and accelerated pathways.
• Knowledge of FDA, EMA and global regulations including ICH guidelines with a strong knowledge of eCTD elements and structure.
• Excellent verbal/written communication and listening skills.
• Proven planning and organizational skills and regulatory writing skills.
• Ability to prioritise and handle multiple CMC regulatory deliverables in a dynamic environment.
• Experience in IND, IMPDs and supporting documentation (i.e Briefing documents).
• Ability to work in a fast-paced environment with a sense of urgency.

Other skills/Attributes:

• Demonstrated alignment with Amicus Mission Focus Behaviors
• Passion for rare disease and patient focused

Travel:

• Some travel might be required

Apply Now

More Job Searches

United Kingdom      Clinical Research      Regulatory Affairs      Amicus Therapeutics