Director, Regulatory Affairs, BeNeLux

The Opportunity:

We are looking for an experienced, pragmatic and business minded Director Regulatory Affairs, BeNeLux reporting solid line to Senior Director, Country Manager Netherlands, and dotted line to Senior Director Country Manager BeLux as well as 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.

Key aspects of this role will include

• Strategic leadership in the development and execution of the regulatory strategy for Belgium, Netherlands and Luxemburg in line with the global and regional goals.

• First product launch readiness; all relevant regulatory activities for the first product indication need to be first-time right and delivered on time in accordance with key requirements, regional/local regulations, and scientific and company policies and procedures.

• Cross-functional business partnership. Pro-actively engaging in local teams and the team of regulatory professionals at global and European level.

• Compliance & product lifecycle management; This role will ensure compliance with the applicant's and/or marketing authorization holder's responsibilities under legislation or regulatory guidelines for assigned products in Belgium, Netherlands and Luxemburg.

• Implement the global and regional governance model for the BeNeLux organization to ensure that all employees are trained and work compliant aligned with local regulations.

The Director, Regulatory Affairs BeNeLux is an essential member of the local Management Teams, while also acting as a contributor within the International 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. 

Further responsibilities include:  

• Support global and regional RA as applicable with the preparation and follow-up for national scientific consultations and pre-submission meetings.

• Coordination of the creation of materials for risk mitigation activities and healthcare professional communication.

• Ensuring that product packaging and related information are updated and maintained in accordance with regulatory requirements.

• Review and approval of promotional materials in accordance with local regulations.

• In collaboration with regional and/or global RA organization represents the regulatory function at internal and external meetings.

• Close monitoring and analysis of all nationally relevant regulatory guidelines and communicates updates and implications to both local, regional and global teams.

• Maintaining knowledge of complex regulatory requirements, contribute to the preparation of new regulatory guidelines wherever possible, comments on draft regulatory guidelines, and communicates changes to regulatory information to project teams and senior management locally and internationally.

• Ensuring compliant and necessary inclusion at local MPAs and relevant platforms to ensure product availability.

• Initiating and contributes to local and/or global process improvements that have a significant impact on the business.

• Leading the creation, maintenance, continuous improvement, training, evaluation, and follow-up of all regulatory-related procedures, including policies, SOPs, manuals, and work instructions, to meet local regulatory requirements.

• Managing quality defects, counterfeit or imitation products, and batch recalls.

• Serving as the information officer.

• Responsible for any distribution and wholesale licenses.

• Managing local regulatory and regulatory compliance audits within the affiliate.

• management and leadership responsibilities, as applicable. Managing affiliate inspections and audits.

• Providing the vision and direction for the RA organization at the country levesl, in line with Global / European RA and the affiliate's vision.

• Plans, monitors, allocates, and optimizes resources and budget with regard to portfolio development and regulatory changes.

• Ensures a well-staffed and appropriately trained affiliate, as applicable.

• Adhere to Revolution Medicines Core Values and policies. 

• Understand the regulatory requirements for customer engagement by field-based employees. 

Required Skills, Experience and Education: 

• Master’s / PhD degree in scientific or medical discipline.

• 10+ years of relevant experience and 5+ years in regulatory leadership roles or in a similar role within the pharmaceutical or biotech industry. Demonstratable specialist knowledge of the European Regulatory Affairs for medicinal products.

• Proven track record in EU market approvals, regulatory submissions and product lifecycle management.

• Deep understanding of the EU regulatory framework and the relevant local requirements in the three BeNeLux countries.

• Excellent verbal and written communication skills Dutch, English required, French is an advantage.

• Proven ability to analyze and summarize scientific information effectively.

• Excellent presentation skills, able 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, pro-active and able to thrive in a fast-paced and dynamic environment.

• Willingness to travel up to 20% of time.

Preferred Skills: 

• Experience in oncology and or innovative biologic or targeted therapies.

• Experience in biotech start-up, scale-up or lean affiliate.

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

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