Senior Director, Regulatory Labeling

Job Description

General Summary:

The Senior Director, Regulatory Labeling is regulatory labeling leader with expert technical and operational experience in regulatory labeling, globally, and is responsible for overseeing the development and maintenance of global product labeling for marketed products, as well as pipeline activities for the cystic fibrosis (CF) portfolio. This will include target labeling profiles and/or company core datasheets and local labeling (prescribing information and patient information). This role will be accountable for business processes specific to the management of marketed product labeling.

Key Duties and Responsibilities:

• Holds primary responsibility for development of product labeling, including core labels and local US and EU labeling, to support CF drug development and all product lifecycle management
• Leads a team of Global Labeling Leads (GLLs) who are responsible for day-to-day labeling activities. Manages team resourcing and product assignments.
• Accountable for compliance with health authority requirements, labeling governance requirements and associated business processes.
• Chairs the marketed product Label Review Group(s) (LRGs) and represents labeling at senior labeling governance meetings (ELRG).
• Leads marketed product and cystic fibrosis labeling strategy including development, management and maintenance of product labeling for the lifecycle of assigned products.
• Challenges the team to provide complete, robust, and clear rationale for labeling changes.
• Advises stakeholders of regulatory labeling requirements for quality, preclinical, and clinical data
• Provides oversight of health authority interactions regarding all aspects of labeling across a therapeutic area, including responses to questions, negotiations, and inspections.
• Identifies opportunities for improvement and leads initiatives, working with cross-functional stakeholders, to ensure compliant and efficient operations within the marketed product labeling team.
• Is part of the Labeling Leadership team and works collaboratively with peers to ensure overall Global Labeling team effectiveness.
• Provides department/company training on labeling practices and policies

Knowledge and Skills:

• A business-minded leader, capable of strategic thinking and proposing innovative solutions to problems
• Demonstrates excellent communication skills with ability to impact and influence the decisions of a team
• Communicates clearly and effectively with all levels within the company and act as liaison / representative of labeling both internally and externally
• Expert-level knowledge regarding labeling requirements globally, including development and life-cycle management of TLPs, CCDS and of global regulatory authorities including the FDA, EMA, and familiarity with other authorities such as Health Canada, TGA.
• Expert ability to develop, use, and apply knowledge of frameworks specific to regulatory global and 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.
• Excellent organizational, analytical, problem-solving, proofreading, and decision-making skills.
• Ability to articulate the organization's strategic vision and core values and successfully contribute to improving the quality of internal regulatory labeling policies, programs and initiatives.
• A strong leader who demonstrates sensitivity and understanding of others' perspectives, and continuously develops staff by providing feedback, coaching, guidance and mentoring.

Education and Experience:

• Typically requires 12 years of relevant pharmaceutical or biotech industry experience within regulatory affairs and 5 years of supervisory/management experience, or the equivalent combination of education and experience

#LI-EE1 #LI-Remote

Pay Range:

Disclosure Statement:

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