Job Description

General Summary:

The Regulatory Labeling Manager is responsible for the development and maintenance of global product labeling for one or more products in one or more rest of the world markets, and associated packaging components, under guidance, for labeling compliance processes across a therapeutic area, and inspection readiness of these business processes. This role may be responsible for the operational execution for specific business processes.

Key Duties and Responsibilities:

• Supports compliance with labeling governance requirements and associated business processes.
• Works with label working groups and supporting labeling discussions at labeling governance meetings, with direct supervision/guidance.
• Supports labeling strategy for a product at the global level and/or across ROW market(s) for a given therapeutic area, including responses to questions, negotiations, and inspections.

Knowledge and Skills:

• Good understanding and knowledge regarding labeling requirements including development and life-cycle management of one or more ROW labels, and of a global health authority.
• 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.
• Ability to plan, prioritize, and execute individual work, related to regulatory global and/or regional labeling in a systematic and efficient manner.
• Proficient, with guidance, in strategic life-cycle management for global or country-specific labels.

Education and Experience:

• Bachelor’s degree in a life sciences field
• Typically requires 4 years of experience in regulatory affairs in the area of global labeling or a related discipline, or the equivalent combination of education and experience

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 [email protected]