Global Labelling Lead

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Offer regulatory expertise, strategic insights, and guidance to internal stakeholders, such as Clinical, Pharmacovigilance, Legal, Scientific, and Commercial teams.

• Oversee the preparation of strategic labeling contributions for regulatory strategies and collaborate with regulatory team members on submission and negotiation strategies.

• Formulate regulatory labeling strategies for new and updated prescribing information and packaging.

• Strategically analyze scientific, medical, and regulatory data and information.

• Provide counsel on current labeling requirements, templates, tools, and Health Authority guidelines for pharmaceutical products and devices.

• Operate under the supervision of the Head of Global Labeling.

⛳️ Requirements

• A bachelor's degree in a related field.

• Extensive experience with a demonstrated history of success in Regulatory Labeling.

• Advanced understanding of the scientific principles involved in the drug development process.

• Comprehensive knowledge of regulations related to drug product labeling.

• Exceptional oral and written communication abilities.

• Strong project management capabilities.

• Outstanding critical thinking skills.

• Meticulous attention to detail.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.