Senior Global Regulatory Scientist

This is a fully remote position, open to applicants in Ireland, +2 more states.

📋 Description

• Oversee the formulation of global regulatory strategies for clinical programs, which includes establishing plans for significant health authority interactions and milestones.

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

• Analyze evolving global regulations, guidelines, and precedents, providing teams with insights on their implications for program design and execution.

• Offer strategic contributions to clinical development plans, risk management strategies, and labeling considerations.

• Act as a representative of regulatory functions during sponsor and health authority meetings.

• Guide junior regulatory staff through mentorship.

• Participate in the development of internal best practices, templates, and knowledge-sharing initiatives.

⛳️ Requirements

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

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

• In-depth knowledge of global clinical development regulations, including FDA, EMA, and ICH, along with 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.

• Demonstrated experience in interactions with health authorities.

• Proven track record of leading cross-functional regulatory projects.

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

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

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, which may include medical, dental, and vision coverage.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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

• Option for home working.