Job Description

General Summary:

The Regulatory Labeling Associate Director will be responsible for strategic development of global labeling (CCDS, USPI, EU SmPC and other markets as necessary) on one or more marketed products. This role 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 represents labeling at senior labeling governance meetings.
• Develops and maintains global product labeling for one or more products. This includes the company core datasheets (CCDS) and local labeling (Prescribing Information (PI) and Patient Information (PIL) for select markets (e.g., US, EU, GB, CA) and may include target label profiles, and/or Instructions for Use (IFUs).
• 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 (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.

Knowledge and Skills:

• 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

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.

#LI-EE1 #LI-Remote

Pay Range:

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:

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.

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 ApplicationAssistance@vrtx.com