Regulatory Manager – Senior Regulatory Manager

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

📋 Description

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

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

• Offer regulatory guidance throughout the entire clinical development life cycle.

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

• Provide strategic regulatory input as needed.

• Develop and review submission documents to ensure compliance with 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 necessary.

• Oversee and coordinate the efforts of 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 staff.

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

• Help establish company standards for high-quality submissions.

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

• Stay updated on 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.

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

• 7 years of regulatory experience is required for the Senior Manager level.

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

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

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

• Demonstrated experience in leading Clinical Submissions.

• Ability to understand and interpret clinical and pre-clinical study results for regulatory strategies and positions.

• Knowledge of clinical trial methodologies, including familiarity with protocols and indications being studied.

• Expertise with 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 diverse tasks in a fast-paced environment.

• Strong record-keeping skills.

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

• Proven ability to resolve project-related challenges and prioritize workloads effectively.

• Excellent verbal and written communication skills in English.

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

🏝️ Benefits

• Employees feel valued for their contributions.

• Employee ideas are appreciated and nurtured.

• Equal Opportunity Employer.

• Reasonable accommodations available during the application process.