SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Precision for Medicine is a Contract Research Organization (CRO) specializing in clinical trial execution, combining clinical expertise with laboratory capabilities and advanced data sciences. The company focuses on oncology and rare disease development.
You will provide regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, pediatric planning, and accelerated procedures. You will ensure timely preparation of well-organized, quality regulatory submissions in compliance with applicable regulations and coordinate preparation of regulatory documents for submission to Regulatory Authorities and Ethics Committees.
Key responsibilities include:
- Provide regulatory guidance throughout the clinical development lifecycle
- Compile, coordinate, and review applications to Regulatory Authorities including CTA/IND submissions, annual reports, routine amendments, scientific advice/regulatory authority meetings, 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 representative of Global Regulatory Affairs at project team meetings with external and internal customers
- Lead projects for the region or globally as needed
- Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
- Maintain project plans, trackers, and regulatory intelligence tools; keep Regulatory Leadership updated
- Assist in development of Regulatory Affairs Specialists and operational staff
- Provide input into regulatory strategy and timeline development for new study opportunities
- Establish company standards to ensure highest quality of submitted information
- Participate in corporate quality initiatives across business units
- Stay current with laws, regulations, and guidelines governing drug development and approval
- Provide ICH GCP guidance, advice, and training to internal and external clients
- Serve as representative at business development meetings
Requirements:
- Bachelor's degree or equivalent experience, ideally in a scientific or healthcare discipline
- 5 years regulatory experience required for Manager level; 7 years for Senior Manager level
- Informed knowledge of all aspects of drug development process including regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US)
- Experience with submissions to Regulatory Authorities including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions
- Regulatory affairs experience working for a CRO or within the Pharmaceutical Industry
- Experience leading Clinical Submissions
- Ability to understand clinical and pre-clinical study results and interpret them for regulatory positions and strategy
- Knowledge of clinical trials methodology, including working knowledge of 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 environment
- Understanding of financial management
- Professionalism, punctuality, and ability to deliver on commitments
- Ability to manage multiple and varied tasks in fast-moving environment with good record-keeping skills
- High self-motivation; ability to work and plan independently and in team environment
- Ability to motivate project team members to meet timelines and goals
- Flexible attitude toward work assignments and new learning
- Problem-solving skills and ability to prioritize workload to meet deadlines with minimal management support
- Focus on continuous improvement and process efficiency
- Ability to collect data of consistently high standard
- Effective English communication skills, both verbal and written
- Ability to conduct formal presentations to diverse audiences
