Amicus Therapeutics (NASDAQ:FOLD) is a biopharmaceutical company at the forefront of therapies for rare and orphan diseases. The Company has a robust pipeline of novel, first-in-class treatments in development for a broad range of human genetic diseases, with a focus on delivering new benefits to individuals with lysosomal storage diseases (LSDs).
The Company is leveraging its Chaperone-Advanced Replacement Therapy (CHART™) platform to develop next-generation ERTs by identifying and co-formulating proprietary therapeutic enzymes with pharmacological chaperones. The lead CHART programs in late preclinical development are AT-B100 co-formulated with the pharmacological chaperone migalastat HCl, a next-generation ERT for Fabry disease; and AT-B200, co-formulated with the pharmacological chaperone AT2220, a next-generation ERT for Pompe disease. Amicus is also evaluating a next-generation ERT for Mucopolysaccharoidosis Type I (MPS I) in preclinical studies. Amicus retains worldwide rights to all applications of its proprietary CHART platform.
Amicus is also developing novel small molecules as monotherapy treatments for Fabry disease and Parkinson’s. Amicus owns global rights to its pharmacological chaperone, migalastat HCl, as a monotherapy for Fabry disease. In addition, the Company has entered collaboration with Biogen Idec to discover, develop and commercialize novel small molecules for the treatment of Parkinson's disease, for further development by Biogen Idec.
Since its inception in 2002, Amicus has been building a world-class leadership, scientific and medical team with proven expertise in drug discovery, development and commercialization, with unique skills and experience suited to rare and orphan diseases. The Company completed an Initial Public Offering in May 2007 and trades on the NASDAQ National Market under the Ticker Symbol: FOLD. Amicus’ headquarters are located in Cranbury, NJ.
SUMMARY OF POSITION
The Manager of Regulatory Affairs will report to the Director, Regulatory Affairs and is accountable for the preparation and management of simple and complex regulatory submissions. The incumbent will work independently and within a group setting to act as liaison between Regulatory Affairs and other functional areas including external CROs, partners, and consultants in the planning, organizing, and preparing of regulatory documents for submission to governmental regulatory agencies. This individual will have a solid understanding of FDA regulations and ICH guidance’s and experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications in Common Technical Document format. The ideal candidate will have excellent written and effective verbal communication skills, proficient in project management, is flexible, and able to work in a fast paced environment.
MAJOR ACTIVITIES AND RESPONSIBILITIES
Reporting to the Associate Director of Regulatory Affairs, the Regulatory Affairs Manager will:
• Actively contribute to the development and implementation of regulatory strategy for assigned projects.
• Prepare, coordinate, manage or maintain simple and complex regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages, etc.) in accordance with applicable regulations; this includes ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival).
• Provide thoughtful & accurate comments during document (e.g., IB, protocol, ICFs, DSURs, annual reports, etc.) review, mindful of regulatory/ICH guidance/requirements pertaining to document content.
• Interface with external regulatory groups (e.g., CRO, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions.
• Act as liaison between Regulatory Affairs and other functional areas; represent Regulatory Affairs in cross-functional team meetings.
• Provide regulatory support for clinical operations activities (e.g., review of essential documents, and development and review of consent forms, etc.).
• Monitor company progress toward fulfillment of regulatory commitments.
• Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments.
• Review and communicate current & emerging regulatory requirements (e.g., US and international regulations and guidelines).
• Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for corporate quality assurance efforts.
• Develop and maintain current regulatory knowledge.
Reports to the Associate Director of Regulatory Affairs
QUALIFICATIONS AND BACKGROUND REQUIREMENTS
• Bachelor’s degree in a scientific discipline or equivalent. Advanced degree or Regulatory Affairs Certification is preferred.
Professional Work Experience
• Candidate must possess a Candidate must have at least 3 to 7 years of Regulatory experience in the pharmaceutical or biotechnology industry, with demonstrated increasing expertise and responsibility.
• Experience working with innovator products and designing and executing creative development strategies are highly desirable.
• Must have a solid understanding of FDA regulations and ICH guidance’s, as well as a comprehension of the drug development process.
• Experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications in Common Technical Document format, is essential.
• Able to handle multiple projects and exercise good judgment in prioritizing tasks.
• Demonstrated ability to work independently and within a group setting, and to interact effectively with various functional groups.
• Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
• High level of attention to detail, and be proficient with Microsoft Office applications, Adobe and document management templates.
Contract position for 12 Months with potential for conversion.
This position will be based at 1 Cedar Brook Drive, Cranbury, NJ, 08512.
Domestic and international travel required.
Amicus is currently seeking qualified candidates in various departments at its Cranbury, New Jersey and San Diego, California locations. With a focus on teamwork and initiative, Amicus offers a fast-paced and entrepreneurial environment where innovative thinking and collaboration are highly-valued and expected. The Company offers attractive compensation and benefit packages to its employees.
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, or any other characteristics protected by applicable federal, state or local law.
Please note that Amicus reviews every submission and will keep all submissions on file for six months. Unsolicited resumes should not be forwarded to Amicus Therapeutics. Amicus Therapeutics will not be responsible for any fees arising from the use of resumes through this source. Amicus Therapeutics will only pay a fee to agencies if a formal agreement between Amicus Therapeutics and the agency has been established