BeNeLux Regulatory Director – Launch Readiness

revolutionmedicines; Nederland; On-site; EUR 180,000 - 250,000; Full time

Job summary

Revolution Medicines is seeking an experienced Director Regulatory Affairs for BeNeLux to lead regulatory strategy across Belgium, the Netherlands, and Luxembourg as the company prepares for European authorization and launch. The role combines strategic input with hands-on execution to ensure launch readiness and compliant processes within a fast-growing organization.

The position reports to Senior Director, Country Manager Netherlands, and dotted line to Senior Director BeLux and VP Regulatory

Responsibilities

• 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. Proactively 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.
• 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 levels, in line with Global / European RA and the affiliate's vision.

Job description

Revolution Medicines is seeking an experienced Director Regulatory Affairs for BeNeLux to lead regulatory strategy across Belgium, the Netherlands, and Luxembourg as the company prepares for European authorization and launch. The role combines strategic input with hands-on execution to ensure launch readiness and compliant processes within a fast-growing organization.

The position reports to Senior Director, Country Manager Netherlands, and dotted line to Senior Director BeLux and VP Regulatory