Director, Regulatory Affairs, Poland

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor - all in service of patients.

The Opportunity:

We are seeking a highly motivated and experienced professional to join our team as Director Regulatory Affairs, Poland reporting solid line to Senior Director, Country Manager Poland, and dotted line to VP Regulatory Affairs Europe. This is a high impact opportunity to shape the local capabilities as RevMed prepares for the anticipated European authorization and launch of its first oncology product. The role combines strategic input with hands-on execution to ensure the affiliates are prepared for launch and establish fit-for-purpose processes for a fast-growing organization. This role will further ensure compliance with the applicant's and/or marketing authorization holder's responsibilities under legislation or regulatory guidelines for assigned products in Poland.The Director, Regulatory Affairs, Poland is an essential member of the local Management Team, while also acting as a contributor within the European Regulatory Team.The candidate will provide regulatory support for assigned products and therapeutic areas and work cross-functionally with medical affairs, clinical development, marketing and other teams to support the development and execution of medical strategies and tactics.

Key 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.

Required Skills, Experience and Education:

• 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.

Preferred Skills:

• Preferred experience in oncology.

• Experience with both early and late-stage clinical assets as well as approved therapies.

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