Manager, Regulatory Affairs - Rare Diseases | BioNJ Talent Services

Manager, Regulatory Affairs - Rare Diseases

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

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

The cornerstone of the Amicus portfolio is GalafoldTM (migalastat). The lead biologics program in the Amicus pipeline is AT-GAA, an investigational therapy for Pompe disease. Amicus is committed to advancing and expanding a robust pipeline of cutting-edge, first- or best-in-class medicines for rare metabolic diseases.

Job Description:

SUMMARY OF POSITION

The Manager of Regulatory Affairs - Rare Diseases will report to the Associate Director, Regulatory Affairs and is accountable for the preparation, coordination, 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 experience with submission and management of clinical trial applications in the EU and a solid understanding of FDA regulations and ICH guidance’s and experience with regulatory submissions, including INDs. Experience with rest of world/international clinical trial applications and marketing applications in Common Technical Document format is a plus. 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.

ROLES AND RESPONSIBILITIES

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 coordinate identified regulatory requirements into reliable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival).


Provide review and comment during document (e.g., IB, protocol, ICFs, DSURs, annual reports, etc.) review, including consideration of regulatory/ICH guidance/requirements pertaining to document strategic purpose and content.


Interface with external regulatory groups (e.g., CRO, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions.


Support Regulatory Affairs activities with other functional areas as required including representing 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, including the authoring and review of standard operating procedures (SOPs).


Remain current on regulatory requirements (e.g., Domestic and International) supporting the regulatory strategy and clinical operations related activities.).

Qualifications: 

QUALIFICATIONS AND BACKGROUND REQUIREMENTS
Bachelor’s or Master’s degree in a scientific discipline or equivalent. Regulatory Affairs Certification is preferred

Candidate must possess at least 3 to 7 years of Regulatory experience in the pharmaceutical or biotechnology industry, with demonstrated increasing expertise and responsibility.


Experience working with innovative products, including biologics, and implementation of 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, with extensive EU Clinical Trial Application experience, is essential.Experience with US INDs, international/rest of world clinical trial applications, and marketing applications in Common Technical Document format is a plus.


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.

Travel
Domestic and international travel required.

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