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About the Role

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

Responsibilities

Lead and provide 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 engage in a team of regulatory professionals at global and European level supporting both early-stage and marketed products.
Ensure compliance with the applicant's and/or marketing authorization holder's responsibilities under legislation or regulatory guidelines for assigned products in the UK & Ireland.
Act as local lead for all interactions with MHRA across the RevMed portfolio.
Support global and regional RA as applicable with the preparation and follow-up for national scientific consultations and pre-submission meetings.
Coordinate the creation of materials for risk mitigation activities and healthcare professional communication.
Collaborate with Supply chain and Quality, ensuring that product packaging and related information are updated and maintained in accordance with regulatory requirements.
Review and approve promotional materials as per local procedures.
Represent the regulatory function at internal and external meetings, in collaboration with regional and/or global RA organization.
Closely monitor and analyze all nationally relevant regulatory guidelines and communicate updates and implications to both regional and global teams.
Maintain knowledge of national regulatory requirements, contribute to the preparation of new regulatory guidelines wherever possible, comment on draft regulatory guidelines, and communicate changes to regulatory information to project teams and senior management locally and internationally.
Participate in industry association groups and regulatory affairs professional societies.
Initiate or contribute to local and/or global process improvements that have a significant impact on the business.
Lead 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.
Manage affiliate inspections and audits.
Manage quality defects, counterfeit or imitation products, and batch recalls.
Serve as the information officer.
Support distribution and wholesale licenses.
Manage local regulatory and regulatory compliance audits within the affiliate.
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.
Adhere to Revolution Medicines Core Values and policies.
Understand the regulatory requirements for customer engagement by field-based employees.

Requirements

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 the UK 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.
Experience working in a Biotech or lean environment.
Experience with both early and late-stage clinical assets as well as approved therapies.

Skills

Regulatory Affairs
Oncology
ICH requirements
Regional/local regulations
MHRA interactions
Scientific consultations
Risk mitigation
Healthcare professional communication
Promotional material review
Regulatory guideline analysis
Process improvement
SOP development
Audit management
Quality defects management
Batch recall management
Distribution and wholesale license support
Budget management
Resource allocation

Location

UK & Ireland

Work Type

Full-time
Hybrid

Experience Level

Senior Director
12+ years

Education Level

Master’s / PhD degree

Salary/Compensations

£139,000—£173,000 GBP

Benefits

Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities

About the Company

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers.
The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins.
The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development.

Equal Opportunity

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.