Regulatory Manager

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

📋 Description

• Offer regulatory guidance throughout the clinical development lifecycle.

• Compile, coordinate, and review submissions to Regulatory Authorities, such as CTA/INDs, annual reports, amendments, scientific advice or regulatory authority meetings, orphan designations, pediatric planning, and marketing applications.

• Develop and/or review submission documents for Regulatory Authorities and Ethics Committees to ensure adherence to regulatory requirements.

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

• Collaborate within project teams and take the lead on regional or global projects as needed.

• 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 regulatory strategy and timelines for new research opportunities.

• Aid in establishing company standards for the quality of submitted information.

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

• Stay updated on current laws, regulations, and guidelines governing drug development and approval.

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

⛳️ Requirements

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

• Proficiency in computer applications, including MS Office/Office 365.

• Fluent in English.

• Over 5 years of relevant experience in regulatory affairs.

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

• Specialized knowledge of regulatory activities for at least one major region, such as the EU or US.

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

• Ability to comprehend clinical and pre-clinical study results and to interpret them in relation to regulatory strategies and positions.

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

• Expertise in regulations and guidance pertinent to pharmaceutical development.

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

• Strong interpersonal skills and capacity to thrive in a team-oriented environment.

• Demonstrates professionalism, punctuality, commitment to obligations, and a service-oriented mindset.

• Capable of managing multiple diverse tasks in a dynamic environment while maintaining accurate records.

• Skilled in both independent and team-based planning and execution.

• Ability to inspire project team members to achieve timelines and objectives.

• Adaptable attitude towards work assignments and ongoing learning.

• Proficient in troubleshooting project-related issues and prioritizing workload with limited managerial oversight.

• Commitment to continuous improvement and process efficiency.

• Capability to gather consistently high-quality data.

• Strong verbal and written communication skills.

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

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance.

• Retirement savings benefits.

• Life insurance.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.