Manager, CMC Regulatory Affairs | BioNJ Talent Services

Manager, CMC Regulatory Affairs

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
Cranbury, NJ
Company Profile: 

COMPANY PROFILE
We are passionate about what we do
Amicus Therapeutics, Inc. (Nasdaq:FOLD) is a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We have a robust development pipeline of treatments for a range of human genetic diseases.

Our lead product candidate, migalastat, is a personalized medicine in late-stage development to treat individuals with Fabry disease on the basis of their genetic diagnosis. SD-101, a product candidate in late-stage development, is a potential first-to-market therapy for the rare genetic connective tissue disorder Epidermolysis Bullosa (EB). We are leveraging our biologics and Chaperone-Advanced Replacement Therapy (CHARTâ„¢) platform technologies to develop novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other Lysosomal Storage Disorders (LSDs). Our lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease ERT that will be administered in combination with a pharmacological chaperone.

Job Description:

POSITION SUMMARY
Manager, CMC Regulatory Affairs manages all regulatory CMC aspects of Amicus Therapeutics throughout their lifecycle with minimum supervision. This includes early development, development/scale up, and commercial products. He/She is responsible for the integration of the regulatory CMC strategy of all submissions and managing interactions with external regulatory consultant services on CMC issues.

ROLES AND RESPONSIBILITIES
Prepare, author, review, coordinate, manage or maintain simple and complex regulatory submissions, including original INDs, IND amendments, IMPDs, annual reports and agency meeting briefing documents in accordance with applicable regulations
Translate regulatory requirements into practical, workable submission plans
Develop and maintain submission timelines for CMC related issues
Coordinate the authoring, review and comment resolution for related submissions
Provide thoughtful & accurate comments during document review with focus on US, international, and ICH regulatory guidelines
Interface with external regulatory groups, such as contract manufacturers, development partners, consultants and technical writers
Act as liaison between Regulatory Affairs and other functional areas
Represent Regulatory Affairs in cross-functional team meetings
Initiate and/or contribute to process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments
Review and communicate current and emerging regulatory requirements
Author and review standard operating procedures (SOPs)
Develop and maintain current regulatory knowledge

Qualifications: 

REQUIREMENTS
The successful candidate must possess a Bachelor’s degree in pharmacy, or process manufacturing related healthcare functional area.
Advanced Scientific or Process Engineering degree is desirable
Regulatory Affairs Certification is preferred
Background in biologics manufacturing process, process validation, and project management are required.
The candidate must have 3 to 5 years of regulatory experience in the pharmaceutical or biotechnology industry as it pertains to CMC regulatory affairs or biologics manufacturing process
Experience working in small molecule is desirable
The candidate must have a solid understanding of FDA regulations, international regulations and the ICH guidelines, as well as a comprehension of the drug development process
Experience with regulatory submissions in Common Technical Document format.
EXPERIENCE AND SKILLS
The candidate must be able to handle multiple projects simultaneously, while exercising good judgment in prioritizing tasks.
The candidate must demonstrate the ability to work independently as well as in matrix team settings.
The candidate must have strong oral, written, and interpersonal communication skills.The candidate must also have a high level of attention to detail with proficiency with Microsoft Office applications, Adobe and document management templates.
TRAVEL
Minimum travel requirement

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Regulatory Affairs
Paid: 
Yes