Regulatory Labelling Associate Director ROW - Regional Labelling

Job Description

General/Position Summary

The Regulatory Labeling Associate Director, Rest of World (ROW) is responsible for development and maintenance of product labeling 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 labeling.
• Ensures compliance with labeling governance requirements and associated business processes.
• Leads Label Working Groups for ROW labeling topics and represents labeling at product-specific regional regulatory teams and senior labeling governance meetings.
• Works with Labeling Operations to ensure alignment with Package Component Labeling.
• Leads labeling strategy with an advanced ability to advise stakeholders of regulatory labeling requirements and oversight of health authority interactions regarding all aspects of labeling, including responses to questions, negotiations and inspections.

Required Education Level

• Bachelor's Degree

Required Experience

• Typically required 10 years of experience in regulatory affairs in the area of global labeling or related discipline or the equivalent combination of education and experience.

Required Knowledge/Skills

• Expert level knowledge regarding labeling requirements globally, use of CCDS or reference label in the development and management of local labeling.
• Expert ability to develop, use, and apply knowledge of frameworks specific to regulatory responsibilities that align with business objectives.
• Expert ability to plan, prioritize, lead and execute individual work, teamwork, and projects related to regulatory labeling in a systematic and efficient manner. This includes the ability to balance cost, risk and benefits when developing timelines, aligning resources and delivering results.

Pay Range:

$161,520 - $242,280

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.

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.