Regulatory Manager – Senior Regulatory Manager

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

📋 Description

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

• Organize and prepare regulatory documents for submission to Regulatory Authorities and/or 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 meetings, orphan designations, pediatric planning, and marketing applications.

• Provide strategic regulatory insights as needed.

• Develop and/or review submission documents to ensure they meet 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 as required.

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

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

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

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

• Aid in establishing company standards for high-quality submissions.

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

• Keep abreast 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.

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

• In-depth knowledge of all aspects of the drug development process, including regulatory milestones.

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

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

• Regulatory affairs experience in a CRO or within the Pharmaceutical Industry.

• Proven experience leading Clinical Submissions.

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

• Familiarity with clinical trials methodology, including a working knowledge of protocols and indications under study.

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

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

• Strong interpersonal skills and ability to work well in a team environment.

• Understanding of financial management.

• Capability to manage multiple varied tasks in a fast-paced environment while maintaining accurate records.

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

• Skill in resolving project-related issues and prioritizing workload with minimal management support.

• Proficient verbal and written communication skills in English.

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

🏝️ Benefits

• Regular full-time employment.

• Flexible remote work arrangement.

• Opportunity to join a rapidly growing global team.

• Employee contributions are valued and nurtured.

• Chance to drive positive change within the company.