Regulatory Labeling Associate Director

Vertex Pharmaceuticals Inc (US); Boston (MA); Hybrid; USD 162,000 - 242,000; Full time

Benefits offered by this job

Medical, dental and vision

Generous PTO

Student loan repayment

Matching charitable donations

401(k)

Job summary

Vertex Pharmaceuticals Inc, a Boston-based global biotechnology company, seeks a Regulatory Labeling Associate Director to lead strategic labeling for one or more products across CCDS, USPI, EuSmPC, and ROW markets. The role includes governance, cross-functional leadership, and regulatory strategy for health authority interactions.

Ideal candidates have extensive experience in global labeling, a life sciences background, and a track record of coordinating labeling across multiple jurisdictions,

Qualifications

• Bachelor's degree in life sciences with 8 years in regulatory labeling.
• Experience leading global labeling for CCDS/USPI/EuSmPC.
• Ability to advise on regulatory labeling strategy and health authority interactions.

Responsibilities

• Develop and maintain global product labeling including CCDS and major markets.
• Lead labeling governance meetings and label working groups.
• Advise stakeholders on regulatory labeling requirements for data.
• Oversee interactions with health authorities on labeling matters.

Skills

Labeling knowledge

Regulatory affairs

Leadership

Cross-functional collaboration

Regulatory strategy

Education

Bachelor’s degree in life sciences

Tools

Labeling systems

Job description

Job Description General Summary

The Regulatory Labeling Associate Director will be responsible for strategic labeling and for executing on one or more products either at the global label-level (CCDS, USPI, EuSmPC) or in multiple ROW countries/regions for a given therapeutic area. This role may be accountable/responsible for specific business processes and may also be responsible for the development and management of a TLP with some guidance.

Key Duties and Responsibilities

Ensures compliance with labeling governance requirements and associated business processes. Leads label working groups and representing labeling at senior labeling governance meetings. Develops and maintains global product labeling for one or more products. This includes the company core datasheets and labeling for the major markets, or multiple rest of world market-specific labels and associated packaging components and may include target label profiles. Contributes to labeling strategy with a proficient ability to advise stakeholders of regulatory labeling requirements for quality, preclinical and clinical data and oversight of health authority interactions regarding all aspects of labeling across a one or more products at the global level or across several ROW markets for a given therapeutic area, including responses to questions, negotiations, and inspections.

Knowledge and Skills

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 global and/or regional labeling, and to use this information to support regulatory responsibilities that align with business objectives. Demonstrates the ability to effectively adopt and leverage emerging technologies, including AI-driven tools, and maintains a continuous learning mindset to strengthen regulatory strategy, decision-making, and operational efficiency. Proactively remains up to date on advances with technology, AI, automation, competitive intelligence and changes in the regulatory environment. Advanced ability to plan, prioritize, lead, and execute individual work, teamwork, and projects related to regulatory global and/or regional labeling in a systematic and efficient manner. Strong understanding of the compliance and operational requirements for labeling

Education and Experience

Bachelor’s degree, with a preference in a life sciences field. Typically requires 8 years of experience in regulatory affairs in the area of global labeling or related discipline, or the equivalent combination of education and experience.

Pay Range

$161,600 - $242,400

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.

Benefits

• From medical, dental and vision benefits
• 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;
2. Hybrid: work remotely up to two days per week;
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.

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.