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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 therapeutics.
You will join the Global Regulatory Affairs team as a Regulatory Manager or Senior Regulatory Manager (level determined by experience) to provide regulatory strategy and guidance throughout the clinical development lifecycle. Your responsibilities will include:
• Providing regulatory guidance and strategy for clinical trial conduct, regulatory agency meetings, orphan designations, pediatric planning, and accelerated procedures
• Compiling, coordinating, and reviewing applications to regulatory authorities (CTA/IND submissions, annual reports, amendments, scientific advice procedures, orphan designations, pediatric planning, and marketing applications)
• Developing and reviewing documents for submission to regulatory authorities and ethics committees to ensure compliance with regulatory standards
• Serving as the Global Regulatory Affairs representative at project team meetings with internal and external customers
• Leading project teams for regional or global regulatory initiatives
• Overseeing and coordinating Regulatory Affairs Specialists to meet submission targets
• Maintaining project plans, trackers, and regulatory intelligence tools
• Assisting in the development of regulatory staff and operational teams
• Contributing to regulatory strategy and timeline development for new study opportunities
• Participating in corporate quality initiatives across clinical solutions business units
• Staying current with evolving drug development laws, regulations, and guidelines
• Providing ICH GCP guidance and training to internal and external clients
• Representing Global Regulatory Affairs at business development meetings
You will work in a fast-paced, multifaceted environment balancing competing demands from research activities and multiple projects. The role requires strong collaboration skills, financial acumen, and the ability to manage complex regulatory submissions independently and as part of a team.
REQUIREMENTS:
• Bachelor's degree or equivalent experience, ideally in a scientific or healthcare discipline
• Minimum 5 years of regulatory affairs experience for Manager level; 7 years for Senior Manager level
• Comprehensive knowledge of the drug development process, regulatory milestones, and specialized expertise in at least one major regulatory 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 pharmaceutical development regulations and guidance
• Availability for domestic and international travel including overnight stays
• Strong interpersonal and communication skills (verbal and written English)
• Ability to manage multiple tasks in a fast-moving environment with strong record-keeping
• Self-motivation and ability to work both independently and collaboratively
• Capability to resolve project-related problems and prioritize workload to meet deadlines
• Proficiency in conducting formal presentations to diverse audiences
• Understanding of financial management principles
