Regulatory Manager / Senior Regulatory Manager

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

📋 Description

• Provide strategic regulatory guidance and development support for clinical trials, regulatory agency interactions, orphan designations, pediatric planning, and expedited processes.

• Coordinate and prepare regulatory submissions for Regulatory Authorities and/or Ethics Committees.

• Offer regulatory counsel throughout the entire clinical development lifecycle.

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

• Develop and/or review submission documents to guarantee adherence to regulatory standards.

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

• Collaborate within project teams and take the lead on regional or global projects as necessary.

• Oversee and guide Regulatory Affairs Specialists to meet submission objectives.

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

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

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

• Aid in the establishment of company standards for the submission of high-quality information.

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

• Keep abreast of drug development laws, regulations, and guidelines.

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

• Represent Global Regulatory Affairs during business development meetings.

⛳️ Requirements

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

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

• A minimum of 7 years of regulatory experience is necessary for the Senior Manager level.

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

• Specialized knowledge regarding regulatory activities in at least one significant region (EU or US).

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

• Background in regulatory affairs, either within a CRO or the Pharmaceutical Industry.

• Proven experience leading Clinical Submissions.

• Capability to comprehend clinical and pre-clinical study findings and interpret them for regulatory strategies and positions.

• Familiarity with clinical trial methodologies, including knowledge of protocols and indications being studied.

• Expertise in relevant regulations and guidance that support pharmaceutical development.

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

• Understanding of financial management principles.

• Capacity to manage multiple and diverse tasks in a dynamic environment.

• Strong record-keeping abilities.

• Proficiency in independent and team-based planning and execution.

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

• Excellent verbal and written communication skills in English.

• Proficiency in delivering formal presentations to colleagues, investigative personnel, and clients.

🏝️ Benefits

• Employees feel valued for their contributions.

• Employee insights and ideas are appreciated and fostered.

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.