Director, Regulatory Labeling Strategy (Remote-Eligible)
Vertex Pharmaceuticals
August 18, 2026
Remote friendly (Boston, MA)
United States
Corporate Functions
General Summary:
The Regulatory Labeling Director will lead the strategic development of global labeling on one or more marketed products, responsible for development and maintenance of global product labeling across a therapeutic area, including TLPs, CCDS, and local labeling (PI, PIL) for major markets. Accountable for specific labeling business processes.
Key Duties And Responsibilities:
- Ensure compliance with labeling governance requirements and associated business processes.
- Lead label working groups (LWG) and represent labeling at product-specific global regulatory teams and senior labeling governance meetings (LRG, ELRG).
- Plan and lead development and maintenance of global product labeling for one or more products, including CCDS and regional labeling (PI, PIL, IFU) for select markets (e.g., US, EU, GB, CA).
- Lead labeling strategy; advise stakeholders on regulatory labeling requirements; oversee health authority interactions (responses, negotiations, inspections).
- Conduct research on labeling precedent, regulations, policies, and related topics.
- May lead one or more therapeutic areas; own strategic development and lifecycle management of labeling, including TLPs.
Knowledge And Skills:
- Experience leading labeling development and regulator negotiation for initial marketing applications or major indication expansions.
- Ability to synthesize complex information into clear messaging across all organizational levels.
- Global depth of knowledge of labeling requirements and lifecycle management of CCDS and regulatory authorities (FDA, EMA, and possibly Health Canada/TGA).
- Advanced ability to apply regulatory-labeling frameworks aligned with business objectives.
- Advanced planning/prioritization/leadership execution skills; strong attention to detail; quality-driven mindset.
- Strong understanding of labeling compliance and operational requirements.
- Ability to leverage emerging technologies (structured content management, AI-driven tools, eLabeling).
- Continuous learning and staying current on technology/AI/automation and regulatory changes.
Education And Experience:
- Bachelor’s degree.
- Typically 10 years of regulatory affairs experience in global labeling or related discipline (or equivalent).
Pay Range:
- $185,600 - $278,400
- Eligible for annual bonus and annual equity awards.
The Regulatory Labeling Director will lead the strategic development of global labeling on one or more marketed products, responsible for development and maintenance of global product labeling across a therapeutic area, including TLPs, CCDS, and local labeling (PI, PIL) for major markets. Accountable for specific labeling business processes.
Key Duties And Responsibilities:
- Ensure compliance with labeling governance requirements and associated business processes.
- Lead label working groups (LWG) and represent labeling at product-specific global regulatory teams and senior labeling governance meetings (LRG, ELRG).
- Plan and lead development and maintenance of global product labeling for one or more products, including CCDS and regional labeling (PI, PIL, IFU) for select markets (e.g., US, EU, GB, CA).
- Lead labeling strategy; advise stakeholders on regulatory labeling requirements; oversee health authority interactions (responses, negotiations, inspections).
- Conduct research on labeling precedent, regulations, policies, and related topics.
- May lead one or more therapeutic areas; own strategic development and lifecycle management of labeling, including TLPs.
Knowledge And Skills:
- Experience leading labeling development and regulator negotiation for initial marketing applications or major indication expansions.
- Ability to synthesize complex information into clear messaging across all organizational levels.
- Global depth of knowledge of labeling requirements and lifecycle management of CCDS and regulatory authorities (FDA, EMA, and possibly Health Canada/TGA).
- Advanced ability to apply regulatory-labeling frameworks aligned with business objectives.
- Advanced planning/prioritization/leadership execution skills; strong attention to detail; quality-driven mindset.
- Strong understanding of labeling compliance and operational requirements.
- Ability to leverage emerging technologies (structured content management, AI-driven tools, eLabeling).
- Continuous learning and staying current on technology/AI/automation and regulatory changes.
Education And Experience:
- Bachelor’s degree.
- Typically 10 years of regulatory affairs experience in global labeling or related discipline (or equivalent).
Pay Range:
- $185,600 - $278,400
- Eligible for annual bonus and annual equity awards.