Director, Regulatory Affairs, BeNeLux

Revolution Medicines

Contract type

Ongoing

Work mode

Remote · Netherlands

Experience

Lead / principal · 10+ years

Job description

Director Regulatory Affairs, BeNeLux at Revolution Medicines, responsible for developing and executing the regulatory strategy for Belgium, Netherlands and Luxembourg and preparing the affiliates for the anticipated European authorization and launch of the company's first oncology product.

At a glance

Employment: Full-time
Work mode: Remote · Netherlands
Languages: Dutch – fluent, English – fluent, French

What you'll do

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; 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
Act as an essential member of the local Management Teams and a contributor within the International Regulatory Team
Provide regulatory support for assigned products and therapeutic areas and work cross-functionally with medical affairs, clinical development, marketing and other teams
Support global and regional RA 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
Ensure 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
Represent the regulatory function at internal and external meetings in collaboration with regional and/or global RA organization
Close monitoring and analysis of all nationally relevant regulatory guidelines and communication of updates and implications to local, regional and global teams
Maintain knowledge of complex regulatory requirements, contribute to the preparation of new regulatory guidelines, comment on draft regulatory guidelines, and communicate changes to regulatory information to project teams and senior management
Ensure compliant and necessary inclusion at local MPAs and relevant platforms to ensure product availability
Initiate and contribute to local and/or global process improvements that have a significant impact on the business
Manage quality defects, counterfeit or imitation products, and batch recalls
Serve as the information officer
Responsible for any distribution and wholesale licenses
Manage local regulatory and regulatory compliance audits within the affiliate
Management and leadership responsibilities, as applicable; manage affiliate inspections and audits
Provide the vision and direction for the RA organization at the country level, in line with Global / European RA and the affiliate's vision
Plan, monitor, allocate, and optimize resources and budget with regard to portfolio development and regulatory changes
Ensure a well-staffed and appropriately trained affiliate, as applicable
Adhere to Revolution Medicines Core Values and policies

What we're looking for

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
Demonstrable 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

Nice to have

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

Your team

Regulatory Affairs BeNeLux

Local BeNeLux affiliate regulatory function, part of the International Regulatory Team and local Management Teams

Save

About Revolution Medicines

A global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers

Revolution Medicines leverages its differentiated RAS(ON) tri-complex inhibitor platform to advance a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS.

Mission

Changing the trajectory of disease for patients with RAS-addicted cancers worldwide

Key facts

Oncology biopharmaceutical
Global, commercial-state oncology company
Advancing a broad, integrated portfolio of oral RAS(ON) inhibitors
Preparing for the anticipated European authorization and launch of its first oncology product

What they value

Follow the science
Challenge assumptions
Act with urgency
Hold ourselves to a high standard of rigor