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Director, Regulatory Affairs

Revolution Medicines

Redwood City, CA, US
  • Job Type: Full-Time
  • Function: Regulatory Affairs
  • Industry: Biotechnology
  • Post Date: 02/06/2023
  • Website: www.revmed.com
  • Company Address: 700 Saginaw Drive, Redwood City, CA, 94063
  • Salary Range: $50,000 - $150,000

About Revolution Medicines

REVOLUTION Medicines discovers and develops new drugs that harness the therapeutic potential of frontier oncology targets on behalf of cancer patients. Our innovative product engine draws inspiration from nature and evolution, which offer insights into cancer targets, disease mechanisms and therapeutic approaches.

Job Description

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Director/Senior Director, Regulatory Affairs will provide leadership, clinical development strategy, and oversight of clinical science deliverables for Revolution Medicines’ clinical programs.

  • Represent Regulatory Affairs in cross functional meetings and initiatives for assigned programs. Participate as an active, engaged team member on core projects and/or provide RA guidance/strategy to Core team members.

  • Develop regulatory strategic plans in collaboration with project teams to execute strategies for regulatory submission. Generate regulatory submission plans, and direct document development, review, and finalization. Collaborate with team members to ensure agreed timelines and milestones are met.

  • Independently or with limited oversight plan, lead the preparation and submission of all sections of all filings to regulatory authorities, including, but not limited to, IND, NDA, CTA and MAA applications and amendments or supplements.

  • Participate in the review of critical documents such as protocols, ICFs, IBs, CSRs, DSURs, etc. to ensure they are compliant with relevant regulations and guidance (e.g. ICH, FDA, EMA, etc.) prior to submission.

  • Provide technical review of clinical data relevant to regulatory submissions.

  • Ensure submissions to regulatory health authorities are complete, well-organized, of high quality, and compliant, working in concert with subject matter experts, external vendors and with Regulatory Operations.

  • Provide interpretation of regulatory health authorities’ feedback, policies and guidelines to RevMed personnel. Serve as the liaison between RevMed and regulatory authorities for assigned products.

  • Manage relationship with external consultants/CROs supporting development of study start up activities.

  • Effectively plan, organize, and conduct, in close collaboration with cross-functional team members, formal meetings with health authorities.

  • Perform and manage effective and timely regulatory intelligence and research, in support of regulatory affairs and oncology clinical development. Monitor current and evolving legislation regulatory guidance, provide risk assessments and recommendations for various regulatory scenarios.

  • Keep current on the FDA OPDP environment and competitive products; communicate such environment to the teams.

  • Maintain an understanding and awareness of existing and emerging legislation and guidelines relevant to oncology and specific product areas that may affect RevMed development programs.

  • Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs.

  • Utilize regulatory expertise and knowledge and collaborate with project teams to resolve complex issues and develop options that maximize likelihood of regulatory success, including approval of marketing applications.

  • Provide regulatory oversight and guidance regarding strategy for regulatory projects that pertain to RevMed development products.

  • Provide organizational support and be prepared to manage direct reports/consultants as the company grows.

  • Contribute to the development and maintenance of regulatory affairs working practices and procedures.

  • Review, write, and present guidelines and SOPs as needed to support high-quality submissions and assure adherence to regulatory requirements. 

Education, Experience and Skills Requirement: 

  • B.A./B.S. in the sciences, with a minimum of 10 years of experience in regulatory affairs within the pharmaceutical/biotechnology industry.

  • Experience in preparation and submission of IND/CTA/NDA/MAA submissions with regulatory agencies, and ability to contribute to the submission of global regulatory applications.

  • Experience working on Phases 1-3 clinical trials.

  • Early stage Oncology experience is required.

  • Familiarity with the interpretation and application of relevant FDA guidelines pertaining to CMC, nonclinical and clinical matters in drug development.

  • Experience interacting directly with the FDA and other health authorities.

  • Proven ability to effectively work collaboratively in cross-functional teams and lead team discussions.

  • Detail-oriented, resourceful, and adaptable to effectively support multiple competing demands and changing priorities. Demonstrating effective prioritization and decision making.

  • Excellent problem-solving ability and organizational skills, while maintaining attention to detail. High energy level, ability to work in a hands-on capacity, respond to a rapidly changing environment, and work effectively in a project team environment.

  • Creative problem solving and strategizing abilities as it pertains to the regulatory requirements for complex filings.

  • Establish and maintain excellent relationships when dealing with sensitive and/or complex issues and tight timelines.

  • Excellent interpersonal skills and the ability to build and maintain positive relationships with management, peers, and members within the Regulatory Affairs department.

  • Excellent verbal and written communication skills.

  • Demonstrated negotiation skills and ability to influence others by presenting alternative options persuasively.

  • Strong project management skills with the ability to plan, organize, and multitask between projects in a fast-paced environment.

  • Consistently drive for results by setting aggressive and achievable goals.

  • A strategic as well as an operational approach with the ability to "think outside the box" and to manage multiple tasks in a fast-paced environment.

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with RevMed culture and values.

  • Some travel required.

Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company’s offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.

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.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy

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