Regulatory Manager – Senior Regulatory Manager

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

📋 Description

• Deliver regulatory strategy and development support for clinical trials, regulatory agency discussions, orphan designations, pediatric planning, and expedited procedures.

• Ensure the prompt preparation of well-structured, high-quality regulatory submissions that comply with applicable regulations.

• Organize and prepare regulatory documents 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 meeting materials, orphan designations, pediatric planning, and marketing applications.

• Provide strategic regulatory insights as needed.

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

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

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

• Oversee 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 personnel.

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

• Help establish company standards for high-quality submitted information.

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

• Keep updated and expand knowledge of 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.

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

• A minimum of 7 years of regulatory experience is 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 or US).

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

• Proven experience leading Clinical Submissions.

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

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

• Knowledge and expertise in relevant regulations and guidance supporting pharmaceutical development.

• Availability for domestic and international travel, including overnight stays.

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

• Understanding of financial management principles.

• Ability to manage multiple diverse tasks in a dynamic environment.

• Strong record-keeping skills.

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

• Ability to inspire project team members to meet deadlines and project objectives.

• Adaptable attitude towards work assignments and eagerness for new learning opportunities.

• Competence in resolving project-related issues and prioritizing workload with minimal management oversight.

• Commitment to continuous improvement and process efficiency.

• Ability to consistently collect high-quality data.

• Proficient verbal and written communication skills in English.

• Skillful in conducting 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 applicants with disabilities.