Regulatory Manager / Senior Regulatory Manager

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

📋 Description

• Offer strategic regulatory guidance and development support for clinical trials, regulatory agency meetings, orphan designations, pediatric planning, and expedited procedures.

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

• Provide regulatory insights throughout the 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.

• Develop and/or assess submission documents to ensure regulatory compliance.

• Represent Global Regulatory Affairs during both 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 objectives.

• 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 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 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 at business development meetings.

⛳️ Requirements

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

• Minimum of 5 years of regulatory experience required for the Manager level.

• At least 7 years of regulatory experience required for the Senior Manager Regulatory level.

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

• Specialized knowledge of regulatory activities in 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 Contract Research Organization (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.

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

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

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

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

• Understanding of financial management principles.

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

• Excellent record-keeping abilities.

• Capability to work and plan independently as well as within a team.

• Proficiency in resolving project-related issues and prioritizing workloads to meet deadlines.

• Effective communication skills in English, both verbally and in writing.

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

🏝️ Benefits

• Employees feel valued for their contributions.

• Input and ideas are appreciated and nurtured, fostering positive change within the company.

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.