Regulatory Affairs Director, Poland – Launch Readiness

Revolution Medicines; Poland; On-site; PLN 661,000 - 1,013,000; Full time

Job summary

Revolution Medicines in Poland seeks a Director of Regulatory Affairs to lead local regulatory strategy and operations in support of upcoming European authorization and launch. You will report to Senior Director, Country Manager Poland, and collaborate with medical affairs, clinical development, marketing, and global teams.

The role requires a Master's or PhD in a scientific field, 10+ years of regulatory leadership experience, fluency in Polish and English, and willingness to travel up to 20%.

Qualifications

• Master's / PhD degree in scientific or medical discipline.
• 10+ years of experience in regulatory leadership roles or in a similar role within the pharmaceutical or biotech industry.
• Strong understanding of regulatory framework in Poland.
• Knowledge and experience within the oncology therapeutic area is a strength.
• Fluency in Polish and English, both written and spoken, is mandatory.
• Proven ability to analyze and summarize scientific information effectively.
• Excellent presentation skills, with the ability to effectively communicate complex scientific data to diverse audiences.
• Strong networking skills with proven ability to successfully build and maintain relationships with local regulatory bodies and healthcare professionals.
• Independent and able to thrive in a fast‑paced and dynamic environment.
• Willingness to travel up to 20% of time.

Responsibilities

• Strategic leadership in the development and execution of the regulatory strategy for Poland in line with the global and regional goals.
• Support global and regional RA as applicable with the preparation and follow-up for national scientific consultations and pre‑submission meetings.
• Coordinate the development of risk minimization materials and communications for healthcare professionals.
• Ensure that product packaging and related product information are updated and maintained in accordance with regulatory requirements.
• Review and approve promotional materials within the scope of Regulatory Affairs.
• Represent the Regulatory Affairs function at internal and external meetings in collaboration with European and global teams, as appropriate.
• Monitor and analyze Polish regulatory guidelines and communicate updates and their implications to European and global teams.
• Maintain knowledge of complex regulatory requirements, contribute to the development of new regulatory guidelines where appropriate, comment on draft guidelines, and communicate regulatory changes to project teams and senior management.
• Ensure compliant and timely completion of applicable local regulatory registrations, listings, and submissions required to support product availability in Poland, within the scope of Regulatory Affairs.
• Initiate or contribute to local and global process improvements with a significant impact on the business.
• Lead the creation, maintenance, continuous improvement, training, evaluation, and follow-up of regulatory procedures, including policies, standard operating procedures (SOPs), manuals, and work instructions, to meet local regulatory requirements.
• Manage local regulatory inspections and regulatory compliance audits within the affiliate, in collaboration with relevant functions.
• Coordinate and manage Regulatory Affairs activities related to quality defects, suspected falsified products, and batch recalls, in collaboration with Quality and other responsible functions.
• Oversee compliance with the company's wholesale distribution authorization in Poland, including its maintenance and relevant regulatory updates, in collaboration with the relevant internal functions.
• Provide leadership and direction for Regulatory Affairs in Poland in line with European and global strategies and affiliate objectives.
• Plan, monitor, allocate, and optimize regulatory resources and budget in relation to portfolio development and regulatory changes.
• Support appropriate staffing and training for regulatory activities, as applicable.
• Understand regulatory requirements for customer engagement by field‑based employees and support compliant practices.
• Adhere to Revolution Medicines' core values, policies, and procedures.

Job description

Revolution Medicines in Poland seeks a Director of Regulatory Affairs to lead local regulatory strategy and operations in support of upcoming European authorization and launch. You will report to Senior Director, Country Manager Poland, and collaborate with medical affairs, clinical development, marketing, and global teams.

The role requires a Master's or PhD in a scientific field, 10+ years of regulatory leadership experience, fluency in Polish and English, and willingness to travel up to 20%.