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Precision for Medicine is a Contract Research Organization (CRO) specializing in clinical trial execution, combining clinical expertise with scientific knowledge, laboratory capabilities, and advanced data sciences. The company has a strong focus on Oncology and Rare Disease.
You will join the Global Regulatory Affairs team as a Regulatory Manager or Senior Regulatory Manager (depending on experience level) in a remote role based in Slovakia. In this position, you will provide regulatory strategy and development guidance throughout the clinical trial lifecycle, ensuring timely preparation of high-quality regulatory submissions in compliance with applicable regulations.
Key responsibilities include:
- Provide regulatory guidance throughout clinical development lifecycle
- Compile, coordinate, and review applications to Regulatory Authorities (CTA/IND, annual reports, amendments, scientific advice procedures, orphan designations, pediatric planning, marketing applications)
- Develop and review documents for submission to Regulatory Authorities and Ethics Committees
- Serve as representative of Global Regulatory Affairs at project team meetings with internal and external customers
- Lead projects for assigned regions or globally as needed
- Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
- Maintain project plans, trackers, and regulatory intelligence tools
- Assist in development of Regulatory Affairs Specialists and operational staff
- Provide input on regulatory strategy and timeline development for new opportunities
- Participate in corporate quality initiatives across business units
- Stay current with 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 collaborative environment supporting groundbreaking cancer therapies and will have the opportunity to contribute ideas and impact positive change.
REQUIREMENTS:
- Bachelor's degree or equivalent experience, ideally in a scientific or healthcare discipline
- 5 years regulatory experience (for Manager level) OR 7 years regulatory experience (for Senior Manager level)
- Informed knowledge of all aspects of drug development process, including regulatory milestones
- Specialized knowledge of regulatory activities for at least one major region (EU, US), including submissions to Regulatory Authorities (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
- Professional demeanor with punctuality and commitment to service culture
- Ability to manage multiple tasks in fast-moving environment with good record-keeping
- High self-motivation and ability to work independently and in teams
- 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 with minimal management support
- Focus on continuous improvement and process efficiency
- Effective English communication skills (verbal and written)
- Ability to conduct formal presentations to diverse audiences
