Regulatory Manager – Senior Regulatory Manager

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

📋 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 Ethics Committees.

• Provide regulatory guidance 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 documents, and marketing applications.

• Deliver strategic regulatory insights as necessary.

• Develop and review submission documents to ensure adherence to regulatory standards.

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

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

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

• 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 development for new study opportunities.

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

• Implement and uphold corporate quality initiatives across Clinical Solutions business units.

• Stay informed and expand knowledge of laws, regulations, and guidelines governing drug development and approval.

• Offer 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; 7 years required for the Senior Manager Regulatory level.

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

• Specialized expertise in regulatory activities for at least one major region (EU or US), including submissions to Regulatory Authorities, INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.

• Experience in regulatory affairs within a CRO or the Pharmaceutical Industry.

• Proven experience leading Clinical Submissions.

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

• Familiarity with clinical trial methodologies, protocols, and indications under investigation.

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

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

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

• Understanding of financial management principles.

• Capacity to manage multiple diverse tasks in a dynamic setting while maintaining accurate records.

• Ability to work independently and collaboratively in a team environment.

• Capability to motivate project team members to achieve timelines and objectives.

• Aptitude for resolving project-related issues and prioritizing workload with minimal management oversight.

• Proficient in effective communication in English, both verbally and in writing.

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

🏝️ Benefits

• Discretionary annual bonus.

• Private medical insurance.

• MultiSport Card.

• Life insurance.

• Pension plan.

• Home working allowance.

• Vacation time.

• Additional benefits.

• Reasonable accommodations for applicants with disabilities.