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Regulatory Labeling Director, Rest of World Lead (Remote)

Semma Therapeutics

Semma Therapeutics

International Falls, MN, USA
Posted on Tuesday, August 22, 2023

Job Description

General Summary:

This is a Remote role based in the UK.

The Regulatory Labeling Director, Rest of World (ROW) is responsible for development and maintenance of product labeling for ROW markets across all therapeutic areas. This includes product, patient, and package labeling and associated business processes.

Key Duties and Responsibilities:

  • Serves as a member of the Global Labelling Leadership Team and International Regulatory Leadership team.
  • Provides individual contribution and leads team of Regional Labeling Leads (RLLs) in development, submission, negotiation, and approval of ROW labeling.
  • Ensures compliance with labeling governance requirements and associated business processes.
  • Leads label working groups and represents labeling at product-specific regional regulatory teams and senior labeling governance meetings.
  • Provide input to labeling operations and oversees associated packaging components across a therapeutic area.
  • Leads labeling strategy with an advanced ability to advise stakeholders of regulatory labeling requirements and oversight of health authority interactions regarding all aspects of labeling, including responses to questions, negotiations, and inspections.

Knowledge and Skills:

  • Expert-level knowledge regarding labeling requirements globally, use of the CCDS or reference label in the development and management of local labeling,
  • Expert ability to develop, use, and apply knowledge of frameworks specific to regulatory regional labeling, and to use this information to support regulatory responsibilities that align with business objectives.
  • Expert ability to plan, prioritize, lead, and execute individual work, teamwork, and projects related to regulatory global and regional labeling in a systematic and efficient manner. This includes the ability to balance quality, cost, risk, and benefits when developing timelines, aligning resources, and delivering results.

Education and Experience:

  • Bachelor’s degree
  • Extensive experience in regulatory affairs in the area of global labeling or related discipline, or the equivalent combination of education and experience.


Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at