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Precision for Medicine is a Contract Research Organization (CRO) that combines clinical trial execution with scientific expertise, laboratory capabilities, and advanced data sciences. The company specializes in Oncology and Rare Disease development.
You will serve as a Regulatory Manager or Senior Regulatory Manager (depending on experience level) on the global team, providing regulatory strategy and development guidance throughout the clinical trial lifecycle. Your responsibilities include:
• Provide regulatory guidance and strategy across all phases of clinical development
• Compile, coordinate, and review applications to regulatory authorities including CTAs/INDs, annual reports, amendments, scientific advice procedures, orphan designations, pediatric planning, and marketing applications
• Develop and review documents for submission to regulatory authorities and ethics committees, ensuring compliance with regulatory standards
• Serve as the Global Regulatory Affairs representative at project team meetings with internal and external customers
• Lead project teams for regional or global regulatory initiatives
• Oversee and coordinate Regulatory Affairs Specialists to meet submission targets
• Maintain project plans, trackers, and regulatory intelligence tools; keep regulatory leadership informed
• Assist in developing Regulatory Affairs Specialists and operational staff
• Provide input on regulatory strategy and timelines for new study opportunities
• Contribute to establishing company standards for high-quality submissions
• Participate in corporate quality initiatives across clinical solutions business units
• Stay current with evolving laws, regulations, and guidelines governing drug development
• Provide ICH GCP guidance and training to internal and external clients
• Represent Global Regulatory Affairs at business development meetings
You will work in a fast-paced environment supporting groundbreaking cancer therapy research, with your ideas valued and your contributions directly impacting the organization.
**Requirements:**
• Bachelor's degree or equivalent experience, ideally in a scientific or healthcare discipline
• Minimum 5 years regulatory experience for Manager level; 7 years for Senior Manager level
• Comprehensive knowledge of the drug development process, regulatory milestones, and specialized knowledge of 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
• Prior regulatory affairs experience working for a CRO or within the pharmaceutical industry
• Demonstrated experience leading clinical submissions
• Ability to understand and interpret clinical and pre-clinical study results for regulatory positioning and strategy
• Working knowledge of clinical trial methodology, protocols, and indications being studied
• Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
• Availability for domestic and international travel including overnight stays
• Strong interpersonal skills and proven ability to contribute to team environments
• Understanding of financial management
• Ability to manage multiple tasks in a fast-moving environment with strong record-keeping skills
• High self-motivation and ability to work independently and collaboratively
• Ability to motivate project team members to meet timelines and goals
• Problem-solving skills and ability to prioritize workload to meet deadlines with minimal management support
• Focus on continuous improvement and process efficiency
• Excellent English communication skills, both verbal and written
• Ability to conduct formal presentations to diverse audiences
