Senior Director/Executive Director, CMC Gene Therapy Regulatory Affairs | BioNJ Talent Services

Senior Director/Executive Director, CMC Gene Therapy Regulatory Affairs

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

Amicus Therapeutics (Nasdaq:FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases.

With one rare disease medicine globally commercialized for Fabry disease, an investigational enzyme replacement therapy (AT-GAA) in late stage development for the treatment of Pompe disease, and a robust gene therapy pipeline and growth platform for lysosomal storage disorders, Amicus Therapeutics is committed to changing the lives of people with these life-threatening conditions.

Job Description:

Position Summary

Senior Director/Executive Director, CMC Gene Therapy Regulatory Affairs will lead and manage the CMC regulatory activities associated the gene therapy products of Amicus Therapeutics throughout the lifecycle. He/She is responsible for the integration of the regulatory CMC strategy of all submissions.

Roles and Responsibilities

This position will:
Develop innovative CMC regulatory strategies and drive the preparation and submission of high-quality CMC sections of clinical and marketing applications for gene therapy products
Lead interactions with regulatory agencies to resolve CMC issues and foster proactive communication with global regulators
Oversee preparation of CMC regulatory submissions, including original IND/IMPD, IND/IMPD amendments, annual reports and agency meeting briefing documents in accordance with applicable regulations in timely manner
Provide technical and regulatory expertise in gene therapy and act as liaison between Regulatory Affairs and other functional areas, such as Technical Operations, Science, and Quality Assurance
Represent Regulatory Affairs in cross-functional strategic team meetings
Translate regulatory requirements into practical, workable submission plans
Review and implement current and emerging global regulatory requirements for gene therapy products
Build high performing team to support current and new gene therapy programs at Amicus
This position will report to the VP of Regulatory Affairs

Qualifications: 

Requirements
The successful candidate must possess a Master’s degree in Pharmacy, Biology, Chemistry or related healthcare functional area
Ph.D. degree in Science or Engineering is highly desirable
Regulatory Affairs Certification is a plus
The candidate must have at least 15 years of regulatory experience in the pharmaceutical or biotechnology industry as it pertains to gene therapy CMC regulatory affairs
The candidate must have 7-10 years of experience in gene therapy or biologics manufacturing, process development, process validation, analytical development, or QC
The candidate must have a solid understanding of current FDA and international regulations, ICH guidelines
The candidate must have a solid understanding of development of innovative products under standard and accelerated pathways

Experience and Skills
The candidate must be able to handle multiple projects simultaneously, while exercising good judgment in prioritizing tasks.
The candidate must be results oriented.
The candidate must demonstrate the ability to mentor direct reports and collaborate on cross-functional teams.
The candidate must have strong oral, written, and interpersonal communication skills.
The candidate must also have a high level of attention to details.

Travel

Up to 20% travel requirement

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