Senior Global Regulatory Scientist

This is a fully remote position, open to applicants in United Kingdom, +3 more states.

📋 Description

• Oversee the formulation of global regulatory strategies for clinical programs, including plans for crucial health authority interactions and milestones.

• Draft and evaluate intricate regulatory documents such as clinical trial applications and significant submission components.

• Analyze evolving global regulations, guidelines, and precedents, providing guidance to teams on the implications for program design and execution.

• Offer strategic insights into clinical development plans, risk management strategies, and labeling considerations.

• Represent regulatory functions during sponsor and health authority meetings, ensuring effective and scientifically sound communication.

• Mentor junior regulatory professionals.

• Contribute to the development of internal best practices, templates, and knowledge-sharing initiatives.

⛳️ Requirements

• A bachelor's degree in a relevant scientific discipline or healthcare-related field.

• Significant experience in regulatory affairs or regulatory science within pharmaceutical, biotech, or CRO settings.

• Strong understanding of global clinical development regulations, including FDA, EMA, and ICH, as well as regional requirements.

• Exceptional scientific, analytical, and critical-thinking abilities.

• Capability to synthesize complex data into regulatory positions.

• Excellent written and verbal communication skills.

• High level of attention to detail.

• Proven track record of interaction with health authorities.

• Demonstrated experience leading cross-functional regulatory projects.

• Willingness to travel as necessary, approximately 10% of the time.

• Legal eligibility to work in the country where this 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.

• Reasonable accommodations available during the recruitment process.

• An inclusive and accessible workplace.