Director, Regulatory Operations | BioNJ Talent Services

Director, Regulatory Operations

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

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 (CHART™) 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

This individual is responsible for the direction and operational execution of regulatory submissions to ensure timely and quality creation and lifecycle management of global submissions in accordance with agency and company standards. He/she will support the implementation and integration of the Regulatory Information Management (RIM) system into current business practices and participate in all regulatory and medical writing operations activities.

Roles and Responsibilities
Leads assigned projects with manageable risks and resource requirements, driving and managing the operational development, publishing, production and archiving of submissions and/or submission components and ensuring high quality regulatory document deliverables.
Oversees implementation and integration of RIM into current business practices.
Develops, implements and oversees maintenance of technologies and infrastructure needed to support regulatory and medical writing operations
Interprets, implements, and ensures compliance with relevant revised and new FDA/ICH regulations
Participate in the development and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation and conduct associated trainings; recommend and help implement associated process improvements.
Assumes other relevant assignments as directed by the Sr. Director of Global Regulatory Affairs

Qualifications: 

Requirements
BS or MS in scientific discipline or equivalent required. Advanced degree and/or RAC certification preferred.
10+ years of regulatory affairs experience with drugs and/or biologics; at least 7 years’ experience in regulatory operations with relevant experience implementing electronic document management systems, and at least 5 years with experience managing direct reports.
Extensive knowledge of global regulations, guidance documents, and initiatives related to regulatory operations including current knowledge of CTD/eCTD format and regulatory submission requirements
Relevant experience implementing and using electronic document management systems
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient
Excellent interpersonal skills, ability to develop important relationships with key stakeholders, excellent analytical skills and an ability to communicate issues in a simple way and to orchestrate plans to resolve issues and mitigate risks

Experience and Skills
Experience in providing feedback and coaching to team members, direct reports, or members of multifunctional teams
Strong awareness of business principles and practices and how customer and compliance activities interrelate with these principles and practices
Strong attention to detail and ability to perform with high level of accuracy and adherence to compliance policy and procedures
Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
Extensive experience with Microsoft Word, Adobe Acrobat, and electronic publishing software. Experience with Starting Point templates preferred.

Travel
0-5%

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