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.

 

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 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 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 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.

 

 

Roles and Responsibilities:

·       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 and US

·       The incumbent will participate, prepare & execute the CMC regulatory strategy for technology transfer of a large molecule.

 

Requirements

 

Educational Requirements

·       Minimum Bachelor’s degree (M.S. or Ph.D. preferred) in a biopharma discipline. 

·       Regulatory Certification (e.g. RAC)

 

Professional Work Experience Requirements

·       7-10 years’ experience in CMC product development, regulatory

·       Experience in managing complex large molecule submissions

·       Experience working with Health Authorities such as EMA, MHRA, FDA, SwissMedic, PMDA, Health Canada etc

·       Experience managing biological product for all regulatory activities

 

 

Experience and Skills

·       Experience with CMC regulatory submissions with strong knowledge of Phase III and commercial licensure for large molecules

·       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)

 

Other skills/Attributes

·       Demonstrated alignment with Amicus Mission Focus Behaviors

·       Passion for rare disease and patient focused

 

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.  Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence.  Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.

 

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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