Regulatory Manager / Senior Regulatory Manager

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Deliver regulatory strategies and development advice for clinical trials, regulatory agency meetings, orphan designations, pediatric planning, and expedited procedures.

• Coordinate and prepare regulatory documentation for submission to Regulatory Authorities and/or Ethics Committees.

• Offer regulatory guidance throughout the clinical development lifecycle.

• Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications.

• Develop and/or review submission documents to ensure compliance with regulatory standards.

• Represent Global Regulatory Affairs at project team meetings with both external and internal stakeholders.

• Collaborate within project teams and lead regional or global projects when necessary.

• Supervise and coordinate Regulatory Affairs Specialists to meet submission targets.

• Maintain project plans, project trackers, and regulatory intelligence tools; keep Regulatory Leadership informed.

• Assist in the development of Regulatory Affairs Specialists and other operational staff.

• Contribute to regulatory strategy and timeline development for new study opportunities.

• Help establish company standards for high-quality submissions.

• Engage in corporate quality initiatives across Clinical Solutions business units.

• Keep current with laws, regulations, and guidelines governing drug development and approval.

• Provide ICH GCP guidance, advice, and training to both internal and external clients.

• Represent Global Regulatory Affairs at business development meetings.

⛳️ Requirements

• Bachelor's degree or equivalent experience, preferably in a scientific or healthcare field.

• 5 years of regulatory experience required for the Manager level.

• 7 years of regulatory experience required for the Senior Manager Regulatory level.

• Comprehensive knowledge of all facets of the drug development process, including regulatory milestones.

• Specialized knowledge of regulatory activities for at least one major region (EU, US).

• Familiarity with submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.

• Experience in regulatory affairs within a CRO or the Pharmaceutical Industry.

• Proven experience in leading Clinical Submissions.

• Ability to comprehend clinical and pre-clinical study results and interpret them for regulatory positions and strategy.

• Knowledge of clinical trial methodologies, including a working understanding of protocols and indications under study.

• Expertise with pertinent regulations and guidance that support pharmaceutical development.

• Willingness to travel domestically and internationally, including overnight stays.

• Understanding of financial management.

• Capability to manage multiple and diverse tasks in a fast-paced environment.

• Strong record-keeping abilities.

• Ability to work and plan both independently and collaboratively within a team setting.

• Skill in resolving project-related issues and prioritizing workload to meet deadlines with minimal management oversight.

• Proficient communication skills in English, both verbal and written.

• Competency in delivering formal presentations to colleagues, investigative staff, and clients.

🏝️ Benefits

• Employees feel valued for their contributions.

• Employee ideas are appreciated and encouraged.

• Equal Opportunity Employer.

• Reasonable accommodations available for the application process.