Regulatory Labeling Senior Manager

Vertex Inc. • Boston, MA

22h • Remote

About The Position

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.

Requirements

• 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.
• 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

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.

Benefits

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior