Vertex Pharmaceuticals

Director, Regulatory Labeling Strategy (Remote-Eligible)

Boston, MA · Director

Sponsorship not specified$186k-$278kDetected 12 days ago

NegotiationRecruitingFDA RegulatoryResearchRegulatory Affairs

About the role

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.

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.
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.

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

$185,600 - $278,400
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.

The Regulatory Labeling Director will lead the strategic development of global labeling on one or more marketed products.
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

This listing is sourced directly from Vertex Pharmaceuticals's careers page and normalized into a canonical job model.