Director, Regulatory Labeling Strategy (Remote-Eligible)

Vertex Pharmaceuticals Inc (US); United States; Remote; USD 186,000 - 278,000; Full time

Job summary

Vertex Pharmaceuticals Inc (US) seeks a Regulatory Labeling Director to lead global labeling strategy for one or more marketed products, overseeing CCDS, PI, PIL and IFU across major markets including US, EU, GB, and CA. The role requires strategic leadership in labeling governance, regulator negotiations, and lifecycle management with critical interactions with FDA, EMA, and other authorities.

The position emphasizes cross-functional leadership, deep regulatory expertise, and the ability to

Qualifications

• Experience leading labeling development and regulator negotiation activities for a new marketing application or major indication expansion.
• Strong ability to translate complex labeling concepts into clear messages for multiple stakeholders.
• Deep knowledge of global labeling requirements and lifecycle management (CCDS, PI, PIL, IFU).

Responsibilities

• Plan, develop and maintain global labeling for one or more Vertex products across major markets (US, EU, GB, CA).
• Lead Label Review Group (LRG) and Executive Label Review Group (ELRG) discussions and regulatory interactions.
• Advise stakeholders on regulatory labeling requirements and oversee health authority responses and inspections.
• Manage lifecycle updates and strategic labeling initiatives, including CCDS and regional labeling.
• Stay current on labeling governance, technology trends, and eLabeling initiatives.

Skills

Labeling strategy

Regulatory liaison

Global labeling

FDA knowledge

Cross-functional leadership

Negotiation

AI in labeling

Education

Bachelor’s degree

Job description

Job Description General Summary:

The Regulatory Labeling Director will lead the strategic development of global labeling on one or more marketed products. This role will be responsible for the development and maintenance of global product labeling across a therapeutic area. This will include target labeling profiles (TLP), company core datasheets (CCDS) and local labeling (prescribing information, patient information) for major markets. This role will be accountable for specific labeling business processes.

Key Duties and Responsibilities:

Ensures compliance with labeling governance requirements and associated business processes. Leads label working groups (LWG) and represents labeling at product-specific global regulatory teams and senior labeling governance meetings: Label Review Group (LRG) and Executive Label Review Group (ELRG). Plan and lead development and maintenance of global product labeling for one or more products. This includes the Company Core Data Sheets (CCDS) and regional labeling (Prescribing Information [PI], Patient Information [PIL], Instructions For Use [IFU]) for select markets (e.g., US, EU, GB, CA). Lead labeling strategy with expert ability to advise stakeholders of regulatory labeling requirements and provide oversight of health authority interactions (responses to questions, negotiations, and inspections) regarding all aspects of labeling. Conducts research related to labeling precedent, regulations, policies, and other topics as necessary to properly advise on potential labeling impacts, strategies, or outcomes. May lead one or more therapeutic areas and be responsible for the strategic development and lifecycle management of labeling for that/those area(s), including TLPs.

Knowledge and Skills:

Experience leading labeling development and regulator negotiation activities for an initial marketing application or major indication expansion. Ability to synthesize complex concepts and actions into simple and clear messaging; communicating at all levels of the organization, from specialized experts to executive management. Specialized depth of knowledge regarding labeling requirements globally, including development and life‑cycle management of CCDS and of global regulatory authorities, including the FDA, EMA, and may include other authorities such as Health Canada, TGA. Advanced ability to develop, use, and apply knowledge of frameworks specific to regulatory labeling, and to use this information to support regulatory responsibilities that align with business objectives. Advanced ability to plan, prioritize, lead, and execute individual work, teamwork, and projects related to regulatory labeling in a systematic and efficient manner. Strong attention to detail with a quality‑driven mindset. Strong understanding of the compliance and operational requirements for labeling. Demonstrates the ability to effectively adopt and leverage emerging technologies, including structured content management for labeling, AI‑driven tools, and eLabeling technologies. Maintains a continuous learning mindset to strengthen Regulatory Labeling decision‑making and operational efficiency. Proactively remains up to date on advances in technology, AI, automation, competitive intelligence and changes in the Regulatory environment.

Education and Experience:

Bachelor’s degree Typically requires 10 years of experience in regulatory affairs in the area of global labeling or related discipline, or the equivalent combination of education and experience. *LI-EE1 At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision‑making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range:

$185,600 - $278,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job‑related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market‑leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week‑long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on‑site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On‑Site: work five days per week on‑site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote

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 [e-mail]. Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion‑dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1‑mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH‑dependent Cushing’s syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X. We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.