Position Description

Associate Director, CMC Regulatory Affairs (Preferred location Princeton, NJ)
Location United States
Requisition ID 1953
# of openings 1
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Associate Director, CMC Regulatory Affairs (CMC RA)

Position Summary

The Chemistry, Manufacturing and Controls (CMC) Regulatory team at Amicus is looking for a seasoned CMC Associate Director, CMC RA role responsible for leading the Chemistry, Manufacturing and Controls (CMC) regulatory activities for small molecule early and late phase projects, including post-approval support.    The Associate Director will work closely with cross-functional subject matter experts in Tech Ops, Science, Quality and Global Regulatory Affairs to ensure the timely development and delivery of the Module 2.3 and Module 3 CTD sections.  The incumbent will drive the CMC regulatory strategy and ensure it is aligned with global health authority expectations. The leader in this role will ensure all CMC regulatory submissions 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 throughout the lifecycle with an ability to work collaboratively across cross-functional teams. 

Roles and Responsibilities

1.           Independently lead and manage multiple CMC development and post approval projects.

2.           Author, compile, and manage CMC sections of assigned regulatory submissions including, but not limited to, Investigation New Drugs (INDs) and Investigational Medicinal Product Dossier (IMPD), New Drug Applications (NDAs), Marketing Authorization applications (MAAs) and Quality Overall Summaries (QOS)

3.           Independently author the CMC elements of regulatory filings and carry out integrated review process for the documents.

4.           Develop the CMC strategy for development and post approval projects with collaboration of team members and subject matter experts.

5.           Assess manufacturing change controls for global impact and guide technical teams on practical aspects of global change management.

6.           Effective collaboration across technical functions to obtain the required source documents and reports that will be incorporated into the Module 3.

7.           Prepares content templates, works with the technical writer and leads the technical team in preparation of submission documents.

8.           Manages the responses for health authority queries by providing CMC leadership, authorship and tracking to ensure response dates are met.

9.           Assures timely delivery of CMC sections for annual commitments such as annual reports

10.         Interpret global regulations and guidance. Identify regulatory opportunity and risks.

11.         Reports to Director, CMC Regulatory

Requirements

Educational Requirements

•            Minimum Bachelor’s degree (M.S. or Ph.D. preferred) in Chemical, and/or, Biological Sciences/relevant discipline

•            Regulatory Certification (e.g. RAC) preferred but not required

Professional Work Experience Requirements

•            7+ years’ experience in CMC regulatory experience

•            Must have a working knowledge of CMC regulatory submissions for pre and post filings.

•            Knowledge of ICH and other governing documents (US and global) and pharmacopeias.

Experience and Skills

•            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

•            Prior experience in the authoring and preparation of CMC sections of regulatory dossiers including electronic submissions

•            Working in a cross functional team environment

•            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 work independently under pressure and manage multiple projects simultaneously

•            Detail/accuracy oriented

Other skills/Attributes

•            Demonstrated alignment with Amicus Mission Focus Behaviors

•            Passion for rare disease and patient focused

Travel

  • Preferred location is Princeton, NJ (with a hybrid work approach)
  • It is expected that any remote workers are able to travel to the office up to 10% of the time

 

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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