Regulatory Manager – Senior Regulatory Manager

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

📋 Description

• Offer regulatory strategy and development support for clinical trials, meetings with regulatory agencies, orphan designations, pediatric planning, and expedited procedures.

• Organize and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees.

• Provide regulatory support 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.

• Develop and review submission documents to ensure they meet regulatory standards.

• Represent Global Regulatory Affairs during internal and external project team meetings.

• Collaborate within project teams and lead regional or global projects as needed.

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

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

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

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

• Help establish company standards for high-quality submissions.

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

• Stay updated on laws, regulations, and guidelines related to drug development and approval.

• Provide guidance, advice, and training on ICH GCP to 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 required for the Senior Manager level.

• Comprehensive 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 in regulatory affairs within a CRO or the pharmaceutical industry.

• Proven experience leading clinical submissions.

• Capable of interpreting clinical and pre-clinical study results for regulatory strategies and positions.

• Familiarity with clinical trial methodology, including protocols and indications.

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

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

• Strong interpersonal skills and a capability to contribute effectively to a team environment.

• Understanding of financial management concepts.

• Ability to manage multiple tasks in a fast-paced environment.

• Excellent record-keeping abilities.

• Capability to work independently as well as collaboratively within a team.

• Aptitude for motivating project team members to achieve timelines and goals.

• Skilled in resolving project-related issues and prioritizing workload.

• Proficient verbal and written communication skills in English.

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

🏝️ Benefits

• Remote work arrangement in Hungary.

• Regular full-time employment.

• Opportunities to collaborate with a growing global team.

• Employee contributions and ideas are valued and encouraged.

• Reasonable accommodations available for applicants with disabilities.