REVOLUTION Medicines
Associate Director, Commercial Regulatory
REVOLUTION Medicines, Redwood City, California, United States, 94061
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit 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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Revolution Medicines is seeking an Associate Director, Commercial Regulatory who will be responsible for managing the internal Medical Legal Regulatory (MLR) review and approval process and overseeing the submission of promotional materials for marketed products to the US Food and Drug Administration (FDA).
The position can be based at our Redwood City, CA site in a hybrid work schedule or remote-based with as needed travel.
Roles and Responsibilities:
Manage the MLR process end-to-end to ensure accurate, timely, and compliant review of materials. Ensure adherence to established MLR procedures and timeline. Oversee MLR calendars and prioritization to effectively manage material volume. Prior to routing materials for review, ensure submissions undergo quality control and are appropriately categorized and referenced. Schedule MLR related meetings serving as the point of contact for meeting coordination. Facilitate MLR meetings and document required changes and comments in Veeva Vault PromoMats during live meetings. Ensure comments are correctly implemented for materials that have been approved with changes. Collaborate with the Commercial Regulatory Reviewer and Regulatory Operations to create and manage timely submissions of promotional materials to the FDA (i.e., FDA Form 2253). Liaise with and guide project owners and external marketing agencies to ensure compliant workflows for all materials. Maintain the material library to ensure active/approved materials are re-reviewed as outlined in the Standard Operation Procedure (SOP). Manage product label updates and collaborate with cross-functional stakeholders to ensure materials are revised, resubmitted for review, and submitted to the FDA on Form 2253. Provide Veeva Vault PromoMats oversight and on-demand submission support, including working with Information Sciences on user account activation and training for project owners. Identify and recommend process innovations and oversee ongoing MLR operational projects with a focus on optimizing the effectiveness and efficiency of the RevMed MLR process. Required Skills, Experience and Education:
Bachelor's degree in business, communications, science or similar focus; or equivalent experience. 6+ years of MLR operations experience in the biotech or pharmaceutical industry for the US market or pharmaceutical advertising agency project management experience. Basic knowledge of the marketing role and tactical execution is preferred (e.g., product launches, convention planning, brand planning, etc.). Basic understanding of the Commercial Regulatory role including familiarity with submissions of promotional materials to the FDA (i.e., FDA Form 2253). Excellent interpersonal and written communication skills are essential in this collaborative work environment. Attention to detail and the ability to effectively manage multiple projects/priorities is essential. Strong software/computer skills - experience with MS Office Suite, Veeva Vault PromoMats or similar systems. Willingness to think outside the box and champion best practices. Ability to adapt to a constantly evolving fast-paced environment. Self-motivated with a strong sense of ownership in areas of responsibility as well as ability to work in a team environment. Preferred Skills:
8+ years of MLR operations experience in the biotech or pharmaceutical industry for the US market or pharmaceutical advertising agency project management experience. Experienced in the submission of promotional materials to the FDA (i.e., FDA Form 2253).
The base salary range for this full-time position is $180,000 to $225,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
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. For additional information, please contact privacy@revmed.com.
#LI-Hybrid #LI-SH1
The Opportunity:
Revolution Medicines is seeking an Associate Director, Commercial Regulatory who will be responsible for managing the internal Medical Legal Regulatory (MLR) review and approval process and overseeing the submission of promotional materials for marketed products to the US Food and Drug Administration (FDA).
The position can be based at our Redwood City, CA site in a hybrid work schedule or remote-based with as needed travel.
Roles and Responsibilities:
Manage the MLR process end-to-end to ensure accurate, timely, and compliant review of materials. Ensure adherence to established MLR procedures and timeline. Oversee MLR calendars and prioritization to effectively manage material volume. Prior to routing materials for review, ensure submissions undergo quality control and are appropriately categorized and referenced. Schedule MLR related meetings serving as the point of contact for meeting coordination. Facilitate MLR meetings and document required changes and comments in Veeva Vault PromoMats during live meetings. Ensure comments are correctly implemented for materials that have been approved with changes. Collaborate with the Commercial Regulatory Reviewer and Regulatory Operations to create and manage timely submissions of promotional materials to the FDA (i.e., FDA Form 2253). Liaise with and guide project owners and external marketing agencies to ensure compliant workflows for all materials. Maintain the material library to ensure active/approved materials are re-reviewed as outlined in the Standard Operation Procedure (SOP). Manage product label updates and collaborate with cross-functional stakeholders to ensure materials are revised, resubmitted for review, and submitted to the FDA on Form 2253. Provide Veeva Vault PromoMats oversight and on-demand submission support, including working with Information Sciences on user account activation and training for project owners. Identify and recommend process innovations and oversee ongoing MLR operational projects with a focus on optimizing the effectiveness and efficiency of the RevMed MLR process. Required Skills, Experience and Education:
Bachelor's degree in business, communications, science or similar focus; or equivalent experience. 6+ years of MLR operations experience in the biotech or pharmaceutical industry for the US market or pharmaceutical advertising agency project management experience. Basic knowledge of the marketing role and tactical execution is preferred (e.g., product launches, convention planning, brand planning, etc.). Basic understanding of the Commercial Regulatory role including familiarity with submissions of promotional materials to the FDA (i.e., FDA Form 2253). Excellent interpersonal and written communication skills are essential in this collaborative work environment. Attention to detail and the ability to effectively manage multiple projects/priorities is essential. Strong software/computer skills - experience with MS Office Suite, Veeva Vault PromoMats or similar systems. Willingness to think outside the box and champion best practices. Ability to adapt to a constantly evolving fast-paced environment. Self-motivated with a strong sense of ownership in areas of responsibility as well as ability to work in a team environment. Preferred Skills:
8+ years of MLR operations experience in the biotech or pharmaceutical industry for the US market or pharmaceutical advertising agency project management experience. Experienced in the submission of promotional materials to the FDA (i.e., FDA Form 2253).
The base salary range for this full-time position is $180,000 to $225,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
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. For additional information, please contact privacy@revmed.com.
#LI-Hybrid #LI-SH1