Job Title

IntroductionWe are currently hiring a Global Labeling & Regulatory Affairs Director for our client, a global pharmaceutical company known for its innovative technology and products.This role involves leading the development and implementation of strategically advantageous labeling for its development-stage programs. This individual will play a key role in shaping global regulatory labeling strategy, working closely with cross-functional teams to ensure alignment with overall regulatory and commercial objectives. This is a 9 to 12-month contract with the possibility of extension or becoming permanent within Canada. Work arrangements will depend on the selected candidates location.ResponsibilitiesDevelop global regulatory Target Product Profiles and draft labeling for development-stage products.Conduct competitive intelligence analysis to inform labeling strategy.Establish and refine labeling strategy processes to ensure 'label drives development' is embedded in regulatory planning.Monitor external regulatory landscape, assess impact of legislative/regulatory developments, and communicate implications to internal teams.Evaluate emerging data and adjust regulatory Target Product Profiles accordingly.Collaborate with market access, commercial, and compliance teams to align labeling strategy with broader business objectives.Track regulatory requirements and advise teams on potential impacts to global labeling programs.Contribute to the development and enhancement of labeling-related standard operating procedures (SOPs).RequirementsMinimum of 7 years of regulatory affairs experience within the pharmaceutical industry.Strong global experience in regulatory affairs, with a focus on the US and EU regulatory environments.Experience in regulatory development projects, including claims and indications, decision support, Core Company Data Sheet (CCDS) delivery, and Target Product Labeling (TPL).Proven ability to manage complex issues and coordinate multiple projects simultaneously.Exceptional relationship-building skills.Strong team player.Excellent written and verbal communication skills.What We OfferWhy apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with onboarding. We will get you going while you get on with the job.About UsBrunel has a reputation for working with some of the best in the business. That is what we continually strive for. Over 45 years, we have created a global network of interesting clients and talented individuals working together through a vast array of services.