Regulatory Manager

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

📋 Description

• Offer regulatory development guidance and advice throughout the clinical development life cycle.

• Compile, coordinate, and review submissions to Regulatory Authorities, including CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications.

• Develop and/or review documents intended for submission to Regulatory Authorities and Ethics Committees.

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

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

• Supervise and coordinate Regulatory Affairs Specialists to meet submission goals.

• Maintain project plans, project trackers, and regulatory intelligence tools while providing updates to Regulatory Leadership.

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

• Contribute to regulatory strategy and timeline development for new study opportunities.

• Help establish company standards for high-quality submissions.

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

• Stay updated and expand knowledge of laws, regulations, and guidelines governing 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.

• Proficient in MS Office/Office 365.

• Fluent in English.

• Over 5 years of relevant experience in regulatory affairs.

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

• Specialized knowledge of regulatory activities in at least one major region (EU or US), covering INDs/CTAs, amendments, scientific advice procedures, and post-approval submissions.

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

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

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

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

• Strong interpersonal skills and capability to work effectively in a team environment.

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

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

• Skilled in resolving project-related issues and prioritizing workload to meet deadlines with minimal management oversight.

• Capability to deliver formal presentations to colleagues, investigative staff, 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.