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Salary: PLN 190,200 - 285,400 / annual
Precision for Medicine is a Contract Research Organization (CRO) specializing in clinical trial execution, combining advanced technologies, scientific expertise, and operational scale to accelerate the development of life-changing therapies. 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 fully remote role based in Poland. In this position, you will provide regulatory strategy and development guidance to optimize the 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 full compliance with applicable regulations.
Key Responsibilities:
- Provide regulatory guidance throughout the clinical development lifecycle
- Compile, coordinate, and review applications to Regulatory Authorities including CTAs/INDs, annual reports, routine amendments, scientific advice procedures, orphan designations, pediatric planning, and marketing applications
- Develop and review documents for submission to Regulatory Authorities and Ethics Committees to ensure compliance with regulatory standards
- Serve as Global Regulatory Affairs representative at project team meetings with external and internal 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; keep Regulatory Leadership updated
- Assist in developing Regulatory Affairs Specialists and operational staff
- Provide input into regulatory strategy and timeline development for new study opportunities
- 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
- Represent Global Regulatory Affairs at business development meetings
Required Qualifications:
- Bachelor's degree or equivalent experience, ideally in a scientific or healthcare discipline
- Minimum 5 years of regulatory experience for Manager level; 7 years for Senior Manager level
- Informed knowledge of all aspects of the 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 (INDs/CTAs and amendments), Scientific Advice Procedures, and post-approval submissions
- Regulatory affairs experience working for a CRO or within the Pharmaceutical Industry
- Proven experience leading clinical submissions
- Ability to understand and interpret clinical and pre-clinical study results for regulatory positions and strategy
- Working knowledge of clinical trials 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
Desired Competencies:
- Strong interpersonal skills and ability to contribute to team environments
- Understanding of financial management
- High professionalism, punctuality, and commitment to service culture
- Ability to manage multiple tasks in fast-moving environments with strong record-keeping
- Self-motivation and ability to work independently and collaboratively
- 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
- Excellent English communication skills, both verbal and written
- Ability to conduct formal presentations to diverse audiences
