What are the responsibilities and job description for the Artwork and Labeling Compliance Specialist - Global Regulatory Affairs, Contractor position at Amicus Therapeutics?
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 Artwork and Labeling Compliance Specialist, Global Regulatory Affairs, assists in all End-to-End commercial labeling and artwork activities, ensuring regulatory compliance and timely execution across global markets.
As a key contributor within Global Regulatory Affairs, the Specialist manages the assigned global artwork portfolio, ensuring compliance with labeling regulations and requirements worldwide, researching industry best practices and other competitive landscape considerations, as well as incorporating insights from prior health authority interactions. They collaborate with internal teams and external vendors to keep projects on track for submission, approval, and implementation.
The Specialist also supports process improvements and enhancements, contributes to the proper use and/or research and development of new tools and technologies, and facilitates compliance-related initiatives and reporting. This role provides opportunities for growth and expansion of responsibilities as expertise in global labeling operations and regulatory strategy develops.
Roles And Responsibilities
Educational Requirements
BS in scientific discipline or equivalent preferred. A combination of education, experience, and training may be considered in place of education/experience listed.
Professional Work Experience Requirements
2 years of pharmaceutical industry experience. This is inclusive of approximately 2 years of pharmaceutical labeling experience (global, US, or EU) or a combination of 2 years of regulatory labeling artwork and/or related experience (e.g., compliance, quality, supply, etc.)
Experience And Skills
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.
Position Summary
The Artwork and Labeling Compliance Specialist, Global Regulatory Affairs, assists in all End-to-End commercial labeling and artwork activities, ensuring regulatory compliance and timely execution across global markets.
As a key contributor within Global Regulatory Affairs, the Specialist manages the assigned global artwork portfolio, ensuring compliance with labeling regulations and requirements worldwide, researching industry best practices and other competitive landscape considerations, as well as incorporating insights from prior health authority interactions. They collaborate with internal teams and external vendors to keep projects on track for submission, approval, and implementation.
The Specialist also supports process improvements and enhancements, contributes to the proper use and/or research and development of new tools and technologies, and facilitates compliance-related initiatives and reporting. This role provides opportunities for growth and expansion of responsibilities as expertise in global labeling operations and regulatory strategy develops.
Roles And Responsibilities
- Supports the regulatory aspects of the development, revision, translation, and implementation of packaging artwork for all markets including information gathering on country-specific requirements.
- Coordinates cross-functional labeling artwork reviews, approvals, and submissions while ensuring regulatory requirements are communicated to Supply Chain and vendors to maintain timelines, quality, and compliance.
- Support labeling team in operational activities such as reviewing SPL/XML, preparing documents for linguistic review, tracking and executing high-quality labeling artwork development, release, and implementation globally.
- Maintains artwork records in labeling systems and databases, tracks and reports compliance, and assists with the change control process. Supports audits, inspections, and issue resolution. Escalates concerns as required to ensure quality and timelines.
- Contributes to the optimization of business practices associated with labeling E2E processes, tools, and technology.
Educational Requirements
BS in scientific discipline or equivalent preferred. A combination of education, experience, and training may be considered in place of education/experience listed.
Professional Work Experience Requirements
2 years of pharmaceutical industry experience. This is inclusive of approximately 2 years of pharmaceutical labeling experience (global, US, or EU) or a combination of 2 years of regulatory labeling artwork and/or related experience (e.g., compliance, quality, supply, etc.)
Experience And Skills
- Must have some work experience in labeling operations, artwork development, review, and approval.
- Familiarity with proofreading, electronic proofreading tools, and XML updates in coordination with a vendor.
- Ability to work in a technical environment with proficiency in MS Office Suite, particularly Excel. Comfortable learning and using tools like Veeva Vault, SharePoint, Change Management Systems, and other regulatory applications to document, track, and manage labeling workflows and compliance activities.
- Experience in process improvement projects and process documentation and reporting.
- Excellent written and verbal communication skills for effective communication with cross-functional stakeholders and Health Authorities.
- Ability to collaborate and interface directly with cross-functional teams and senior management as appropriate on labeling artwork content and requirements and negotiate and influence where necessary.
- Proven ability working on innovative products and identifying and incorporating creative labeling solutions through research.
- Other skills/Attributes
- 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.
- Requires approximately 5% domestic travel.
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.