Senior Director, Regulatory Affairs, Spain and Portugal

The Opportunity:

We are seeking a highly motivated and experienced professional to join our team as a Senior Director, Regulatory Affairs, Spain and Portugal. Key aspects of this role will include leading and providing strategic input on all regulatory activities for assigned projects and territories in accordance with ICH requirements, regional/local regulations, and scientific and company policies and procedures, cross-functionally engaging in a team of regulatory professionals at global and European level supporting both early-stage and marketed products. 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 Spain and Portugal.

The Senior Director Regulatory Affairs is an essential member of the local Management Team, while also acting as a strong and active member of 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.

• send promotional materials to the authorities and annual report submission.

• in collaboration with regional and/or global RA organization represents the regulatory function at internal and external meetings, as applicable.

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

• maintains knowledge of complex regulatory requirements, contributes 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.

• participates in industry association groups and regulatory affairs professional societies.

• initiates or 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 affiliate inspections and audits.managing quality defects, counterfeit or imitation products, and batch recalls.

• responsible for distribution and wholesale licenses.

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

• management and leadership responsibilities, as applicable.

• providing the vision and direction for the RA organization at the country level, 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 Education, Experience and Skills: 

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

• 12+ years of experience in regulatory leadership roles or in a similar role within the pharmaceutical or biotech industry.

• Strong understanding of regulatory framework in Spain and Portugal and the EU.

• Knowledge and experience within the oncology therapeutic area.

• Excellent verbal and written communication skills.

• 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 30% of time.

Preferred Education, Experience and Skills: 

• Preferred experience in oncology.

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

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