• Job Description

  Req#: 1250

  Senior Manager, Regulatory Submissions Management, Global Regulatory Affairs

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

  Position Summary

  The Manager/Senior Manager, Regulatory Submissions Management is responsible for managing regulatory submission projects and driving execution of submission content plans through collaboration with cross-functional team members.

  The individual in this role is responsible for planning and tracking progress of all components of a regulatory submission dossier and managing all relevant submission activities in the Veeva Vault Regulatory Information Management (RIM) system and will act as subject matter expert for producing a dossier based on submission strategy, ensuring compliance to required format (i.e., eCTD, NEES, paper, etc.).

  Roles and Responsibilities

  1. Independently manage various regulatory submission projects across various stages of development in all regions (US, EU, ROW), including development of reliable submission content plans, with minimal guidance

  2. Plan and actively manage submission timelines, including timelines for completion of certain submission components. Also track progress of components of a regulatory submission dossier

  3. Lead and drive cross-functional teams focused on the identification, planning and execution of global regulatory submissions, anticipating regulatory obstacles and emerging issues and developing solutions, including end-to-end submissions throughout a product’s lifecycle (i.e., early/late development, post-marketing, etc.)

  4. Lead and facilitate submission planning meetings effectively, ensuring clear communication of actions and decisions to the team

  5. Enter and track project and submission data in Regulatory Information Management system

  6. Work directly with regulatory leads and liaisons in developing submission content plans, and generating certain regulatory administrative components

  7. Work directly with publishing colleagues and vendors, to ensure an accurate and quality assembly of submission dossiers

  8. Provide input, participate, and/or lead department initiatives with a focus on ongoing improvement of regulatory submission management processes and tools, developing and contributing to new regulatory processes and SOPs and support training of key personnel, as needed

  9. Track company progress toward fulfillment of regulatory commitments

  10. Monitor impact of changing regulations on submission strategies and update internal stakeholders

  Requirements

  Educational Requirements

  • Bachelor’s or Master’s degree in a scientific discipline, regulatory affairs or equivalent required. Project Management certification (i.e. PMP) and/or Regulatory Affairs Certification (RAC) is preferred

  Professional Work Experience Requirements

  • Candidate must possess 3-5 years of global regulatory affairs experience with drugs and/or biologics; at least 2 years’ experience in regulatory submissions management; at least 1-2 years’ experience in global markets

  Experience and Skills

  • Strong project management skills; experience in managing projects, and leading cross-functional teams in the development and execution of submission content plans

  • Proficient in the use of the Microsoft Office Suite, Adobe Acrobat, a recognized Project Management application, document and registration Regulatory Information Management systems, eCTD viewers and other web-based applications

  • Working knowledge of global regulatory practices, electronic submission guidelines and global dossier requirements, and various submission and registration types

  • Working knowledge of various application types (CTA, IND, NDA, BLA, MAA, etc.) across all stages of product development

  Other skills/Attributes

  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems

  • Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously

  • High level of attention to detail

  • Must be able to innovate, analyze, and solve problems with minimal supervisory input

  • Demonstrated alignment with Amicus Mission Focus Behaviors

  • Passion for rare disease and patient focused

  Location

  • Princeton, NJ or Remote (with a hybrid work approach)

  Travel

  • Up to 10%

  We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.

  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, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.

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• About the company

  Amicus Therapeutics, Inc. is a biotechnology company. The Company is engaged in the discovery, development and commercialization of a set of treatments for patients living with devastating rare and orphan diseases. Its lead product, migalastat HCl is a...

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