Regulatory Manager – Senior Regulatory Manager

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

📋 Description

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

• Prepare and organize comprehensive, high-quality regulatory submissions that adhere to relevant regulations.

• Coordinate and develop regulatory documents for submission to Regulatory Authorities and/or Ethics Committees.

• Provide regulatory support throughout the lifecycle of clinical development.

• Compile, coordinate, and review Clinical Trial Applications (CTAs)/Investigational New Drug (IND) applications, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan drug designations, pediatric planning, and marketing applications.

• Create and assess submission documents to ensure alignment with regulatory standards.

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

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

• Supervise and coordinate the efforts of Regulatory Affairs Specialists to meet submission deadlines.

• 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 strategies and timelines for new study initiatives.

• 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 that govern drug development and approval processes.

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

⛳️ Requirements

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

• A minimum of 5 years of regulatory experience is required for the Manager role; 7 years for the Senior Manager position.

• Thorough understanding of all aspects of the drug development process, including regulatory milestones.

• Specialized knowledge 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 in leading Clinical Submissions.

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

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

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

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

• Understanding of financial management principles.

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

• Strong record-keeping abilities.

• Proficiency in working independently and collaboratively within a team environment.

• Aptitude for resolving project-related issues and prioritizing workloads effectively.

• Ability to gather data of consistently high quality.

• Excellent verbal and written communication skills in English.

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

🏝️ Benefits

• Discretionary annual bonus.

• Private medical insurance.

• MultiSport Card.

• Life insurance.

• Pension.

• Home working allowance.

• Vacation.

• Recognition of employee contributions and appreciation.

• Reasonable accommodations for applicants with disabilities.