Regulatory Manager / Senior Regulatory Manager

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

📋 Description

• Deliver regulatory strategy and developmental guidance for clinical trials, regulatory agency meetings, orphan designations, pediatric planning, and expedited procedures.

• Ensure the timely preparation of well-organized, high-quality regulatory submissions that comply with relevant regulations.

• Coordinate and prepare regulatory documentation for Regulatory Authorities and Ethics Committees.

• Offer regulatory guidance throughout the entire clinical development lifecycle.

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

• Provide strategic regulatory insights as needed.

• Develop and review submission documents intended for Regulatory Authorities and Ethics Committees.

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

• Collaborate within project teams and lead regional or global initiatives as required.

• Oversee and coordinate the efforts of Regulatory Affairs Specialists to meet submission targets.

• Maintain project plans, trackers, and regulatory intelligence tools; provide updates to Regulatory Leadership.

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

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

• Aid in establishing company standards for the quality of submitted information.

• Implement and uphold corporate quality initiatives across Clinical Solutions business units.

• Stay informed about 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 in business development meetings.

⛳️ Requirements

• Bachelor’s degree or equivalent experience, preferably in a scientific or healthcare-related field.

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

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

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

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

• Regulatory affairs experience 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 strategies and positions.

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

• Familiarity with relevant regulations and guidance that support pharmaceutical development.

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

• Strong interpersonal skills and the ability to contribute effectively in a team environment.

• Understanding of financial management.

• Capability to manage multiple and diverse tasks in a fast-paced environment while maintaining thorough records.

• Proficiency in independent planning and teamwork.

• Ability to motivate project team members to achieve timelines and objectives.

• Competence in resolving project-related issues and prioritizing workloads with minimal management support.

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

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

🏝️ Benefits

• Employees feel appreciated for their contributions.

• Employee ideas are valued and nurtured.

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.

• Privacy and data protection support for applicants.