Senior Manager, Global Regulatory Affairs Labeling

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

Position Summary

The Senior Manager, Global Regulatory Affairs Labeling plays a key role in leading end-to-end labeling activities for Amicus’ commercial and development-stage programs in the rare disease space. This role contributes to the development, maintenance, and execution of global labeling strategies across the product lifecycle.

The Senior Manager acts as a core member of the Labeling Working Group (LWG), supporting the coordination of cross-functional discussions and driving alignment on proposed labeling updates. The individual provides regulatory input and strategic context to guide internal stakeholders on labeling development and revision considerations, ensuring alignment with health authority expectations and company standards.

• Drives End-to-End labeling process and strategy for the development, lifecycle management, and implementation of the TLP, CCDS, and local labeling (i.e., prescribing/patient information and packaging/artwork) in all markets to support successful commercialization and market expansion.  Synthesizes labeling strategy through competitive landscape analysis, regulatory guidance, health authority feedback, and historical experience/labeling negotiations.
• Facilitates cross-functional stakeholder review and consensus of proposed labeling content via the Labeling Working Group and Labeling Review Committee (i.e., executive governance committee) prior to internal approval and/or submission of labeling to health authorities.  Independently recommends labeling strategies including the evaluation of risk and mitigation strategies. 
• Manages the preparation of submission-ready labeling and artwork components for all markets; consults with Regulatory Liaisons and other vendors regarding Health Authority requirements and evolving internal and external submission and negotiation plans.
• Ensures quality and compliant labeling and oversight via proper management of labeling files following the proper processes and utilizing available tools (e.g., document management system, QC of the CCDS and other labeling documents, and documentation of labeling tracking information).
• Supports all market-specific Health Authority labeling inspections, negotiations, and query responses and deviations and coordinates cross-functional alignment and approvals as needed.
• Identifies the need and contributes to the development of continuous improvement of business practices associated with labeling processes and tools. 

• BS in scientific discipline or equivalent preferred. Advanced degree (MSc, PhD, PharmD, or JD) preferred, but not required.

• 7+ years of pharmaceutical industry experience. This is inclusive of approximately 5 years of pharmaceutical labeling experience (global, US, or EU) or a combination of 7+ years of regulatory and/or related experience (e.g., safety, ad promo, regulatory strategy, medical affairs, etc.)

• Must have a detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling and artwork, including EU, US, and ROW labeling requirements and guidance and demonstrated ability to understand implications of label changes on pending and approved labels.
• Expertise in the development and maintenance of Target Product Profiles (TPPs), CCDS, USPI, EU SmPC/PIL, and ROW labeling.
• Proficiency in labeling tools, such as Electronic Document Management Systems, End-to-End (E2E) Labeling Trackers, and Artwork Management Systems to support labeling documentation, tracking, and compliance activities.
• Excellent written and verbal communication skills for effective communication with cross-functional stakeholders, Health Authorities, and adoption of complex data and scientific information into patient and prescribing information.
• Ability to build, engage, collaborate and interface directly within Regulatory, as well as with cross-functional teams and senior management as appropriate on labeling content and requirements and negotiate and influence where necessary. 
• Proven ability working on innovative products and independently identifying creative labeling solutions and strategies.

• Demonstrated alignment with Amicus Mission Focus Behaviors.
• Passion for rare disease and patient-focused.
• Proven strength in logical, analytical and writing ability is essential.
• Strong project management skills and attention to detail required.
• Proven ability to negotiate, influence and problem solve.
• Proven ability to make sound decisions even in ambiguous situations.
• Ability to operate in a fast-paced environment, manage own time for all projects, and work on multiple tasks and ongoing projects simultaneously.
• Good team player willing to contribute to the overall success and needs of the team.   

• Requires approximately 5% domestic travel.

Please note: This is not an exhaustive list of job responsibilities. A detailed job description will be provided during the application process.

Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, colour, 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.

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.