Regulatory Labeling Senior Manager

Job Description

General Summary:

The Regulatory Labeling Senior Manager, Rest of World (ROW) is responsible for development and maintenance of product labelling for ROW markets across all therapeutic areas. This includes prescribing and patient information and associated business processes.

Key Duties and Responsibilities:

• Provides individual contribution in development, submission, negotiation and approval of ROW labelling.
• Ensures compliance with labelling governance requirements and associated business processes.
• Participates in label working groups and representing labelling at labelling governance meetings.
• Works with Labelling Operations to ensure alignment with Package Component Labelling
• Provides input into strategy for health authority interactions and advises stakeholders of regulatory labelling requirements regarding all aspects of labelling, including responses to questions, negotiations and inspections.

Knowledge and Skills:

• In-depth conceptual and practical knowledge regarding labelling requirements globally, use of CCDS or reference label (US and EU) in the development and management of local labelling.
• Ability to develop, use, and apply knowledge of frameworks specific to regulatory regional labelling, and to use this information to support regulatory responsibilities that align with business objectives.
• Ability to plan, prioritize, lead, and execute individual work, and teamwork related to regulatory global and/or regional labelling in a systematic and efficient manner.

Education and Experience:

• Bachelor’s degree
• Extensive 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:

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. 

#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]