Regulatory Labeling Associate Director

** Job Description
**** General/Position Summary
** The Regulatory Labeling Associate Director, 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.
* Leads Label Working Groups for ROW labelling topics and represents labelling at product-specific regional regulatory teams and senior labelling governance meetings.
* Works with Labeling Operations to ensure alignment with Package Component Labeling.
* Leads labelling strategy with an advanced ability to advise stakeholders of regulatory labelling requirements and oversight of health authority interactions regarding all aspects of labelling, including responses to questions, negotiations and inspections.
** Required Education Level
*** Bachelor’s Degree
** Required Experience
*** Extensive years of experience in regulatory affairs in the area of global labelling or related discipline or the equivalent combination of education and experience.
** Required Knowledge/ Skills
*** Expert level knowledge regarding labelling requirements globally, use of CCDS or reference label in the development and management of local labelling.
* 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 labelling in a systematic and efficient manner. This includes the ability to balance cost, risk and benefits when developing timelines, aligning resources and delivering results.  At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends.

We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
** 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.