Regulatory Manager
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Job Description
Regulatory Manager guiding clinical-trial submissions for Precision for Medicine. Advising project teams on regulatory strategy, compliance, and drug-development approvals.
Responsibilities:
- Provide regulatory guidance throughout the clinical development life cycle
- Compile, coordinate, and review applications to Regulatory Authorities, including 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 regulatory compliance
- Represent Global Regulatory Affairs at project team and business development meetings with external and internal customers
- Work within project teams and lead regional or global projects when necessary
- Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
- Maintain project plans, trackers, and regulatory intelligence tools; keep Regulatory Leadership updated
- Assist in developing Regulatory Affairs Specialists and other operational staff
- Provide input into regulatory strategy and timelines for new study opportunities
- Help establish company standards for high-quality submitted information
- Participate in corporate quality initiatives across Clinical Solutions business units
- Maintain current knowledge of laws, regulations, and guidelines governing drug development and approval
- Provide ICH GCP guidance, advice, and training to internal and external clients
Requirements:
- Bachelor's degree or equivalent experience, ideally in a scientific or healthcare discipline
- Computer literacy, including MS Office/Office 365
- Fluent in English
- 5+ years of relevant regulatory affairs experience
- Informed knowledge of all aspects of the drug development process, including regulatory milestones
- Specialized knowledge of regulatory activities for at least one major region, including the EU or US
- Experience with submissions to Regulatory Authorities, including INDs/CTAs, amendments, Scientific Advice Procedures, and post-approval submissions
- Ability to understand clinical and pre-clinical study results and interpret them for regulatory positions and strategy
- Knowledge of clinical trial methodology, protocols, and indications being studied
- Knowledge and expertise in regulations and guidance supporting pharmaceutical development
- Availability for domestic and international travel, including overnight stays
- Strong interpersonal skills and ability to contribute to a team environment
- Professionalism, punctuality, ability to deliver on commitments, and service orientation
- Ability to manage multiple varied tasks in a fast-moving environment and maintain good records
- Ability to work and plan independently and in a team environment
- Ability to motivate project team members to meet timelines and goals
- Flexible attitude toward work assignments and learning
- Ability to resolve project-related problems and prioritize workload with limited management support
- Focus on continuous improvement and process efficiency
- Ability to collect consistently high-quality data
- Effective verbal and written communication
- Proficiency in 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
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