Manager, Regulatory Affairs

The Opportunity:

• Manage planning, preparation (including authoring when appropriate), coordination, and submission of regulatory documents to global National Health Authorities that meet ICH and FDA standards, and other local or regional regulatory requirements.

• Such submissions may include Clinical and Preclinical content.

• Assist and keep detailed timelines for regulatory activities and submissions.

• Perform regulatory research to assess regulatory implications and inform business strategy for drug development and approval.

• Assess and communicate risks.

• Ensure that there are no significant interruptions to the business due to regulatory compliance issues.

• Correspond and collaborate across the organization at all levels, across functional groups, and with executive management.

• Support NDA filing activities and assist with developing regulatory process supporting the filing.

• Prepare and manage routine submissions and related activities.

• Develop regulatory strategies to inform associated budgets, tools and specialized support necessary for efficient operations.

• Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects.

Required Skills, Experience and Education:

• Bachelor’s degree or equivalent in Regulatory Science or related degree in Life Science or Health Science fields.

• Three (3) years of experience in Regulatory Affairs department at a drug or biologics company.

• Employer will accept a Master's degree or equivalent in Regulatory Science or related degree in Life Science or Health Science fields and one (1) year of experience in Regulatory Affairs department at a drug or biologics company.

• Work experience to include:

• Manage the preparation and submission of initial IND (Investigational New Drug) application and subsequent amendments;

• Manage the development of regulatory submissions in eCTD (electronic Common Technical Document) format;

• Interpret and apply FDA (Food and Drug Administration), ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), EMA (European Medicines Agency), or PMDA (Pharmaceuticals and Medical Devices Agency) regulations to oncology drug development;

• Manage global regulatory health authority filings and subsequent amendments.

• Successful completion of background checks and employment history verification required.

• 100% remote position reporting to Revolution Medicines, Inc. in Redwood City, CA. Candidate may live anywhere in the continental U.S.