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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, including regulatory agency meetings, orphan designations, pediatric planning, and accelerated procedures
• Compile, coordinate, and review applications to regulatory authorities (CTA/IND submissions, annual reports, amendments, scientific advice procedures, post-approval submissions)
• Develop and review documents for submission to regulatory authorities and ethics committees to ensure 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 leadership informed
• Assist in developing Regulatory Affairs Specialists and operational staff
• Provide input on regulatory strategy and timelines for new study opportunities
• Contribute to company quality standards and corporate quality initiatives
• Stay current with evolving drug development laws, regulations, and guidelines
• 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, multifaceted environment balancing competing demands from multiple research activities. The role requires strong project management, financial acumen, and the ability to motivate cross-functional teams to meet timelines and goals.
REQUIREMENTS:
• Bachelor's degree or equivalent experience, ideally in a scientific or healthcare discipline
• Minimum 5 years regulatory affairs experience for Manager level; 7 years for Senior Manager level
• Comprehensive knowledge of drug development processes, regulatory milestones, and specialized expertise in at least one major region (EU or US), including submissions to regulatory authorities (INDs/CTAs, amendments, scientific advice procedures, 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 pharmaceutical development regulations and guidance
• Availability for domestic and international travel including overnight stays
• Strong interpersonal skills and proven ability to work effectively in team environments
• Understanding of financial management
• Ability to manage multiple tasks in a fast-moving environment with strong record-keeping
• High self-motivation and ability to work both independently and collaboratively
• Excellent English communication skills (verbal and written)
• Ability to conduct formal presentations to diverse audiences
• Proactive problem-solving and continuous improvement mindset
