Regulatory Manager – Senior Regulatory Manager

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

📋 Description

• Offer regulatory strategy and developmental guidance throughout the course of clinical trials.

• Facilitate meetings with regulatory agencies, manage orphan designations, pediatric planning, and expedited procedures.

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

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

• Create and/or review submission documents to ensure adherence to regulatory standards.

• Represent Global Regulatory Affairs during project team and business development meetings with both internal and external stakeholders.

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

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

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

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

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

• Assist in establishing company standards for high-quality submitted information.

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

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

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

⛳️ 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; 7 years for the Senior Manager level.

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

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

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

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

• Proven experience leading Clinical Submissions.

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

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

• Expertise with relevant regulations and guidance supporting pharmaceutical development.

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

• Understanding of financial management.

• Capability to manage multiple and diverse tasks in a fast-paced environment.

• Strong record-keeping abilities.

• Competence to work and plan independently as well as in a team setting.

• Skill in resolving project-related issues and prioritizing workload to meet deadlines.

• Ability to collect data of consistently high quality.

• Effective verbal and written communication skills in English.

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

🏝️ Benefits

• The job posting indicates that employees feel valued for their contributions.

• Employee ideas are recognized and developed, providing opportunities for positive change.

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.