Current jobs related to Regulatory Affairs Specialist - Redwood City, California - REVOLUTION Medicines

  • Regulatory Affairs Director

    4 weeks ago

    Redwood City, California, United States Biomea Fusion, Inc. Full time

    Job Title: Associate Director, Regulatory AffairsBiomea Fusion, Inc. is seeking an experienced Associate Director, Regulatory Affairs to support the company's regulatory affairs strategies for IND/CTA/BLA/NDA filings and approvals.Key Responsibilities:Lead interactions and act as Subject Matter Expert on regulatory pharmaceutical and/or biotechnology...

  • Director of Regulatory Affairs

    4 weeks ago

    Redwood City, California, United States Nuvig Therapeutics Inc. Full time

    Transformative Therapies for Autoimmune DiseasesNuvig Therapeutics is pioneering novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are designed to be active for a wide range of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with existing therapies.Director, Regulatory...

  • Regulatory Affairs Manager

    3 weeks ago

    Redwood City, California, United States Revolution Medicines Full time

    Revolution Medicines: A Leader in Precision OncologyWe are seeking a highly skilled Senior Manager of Regulatory Affairs to join our team at Revolution Medicines, a clinical-stage precision oncology company dedicated to developing novel targeted therapies for RAS-addicted cancers.The OpportunityAs a key member of our Regulatory Affairs team, you will provide...

  • Regulatory Affairs Director

    4 weeks ago

    Redwood City, California, United States Work In Biotech Full time

    Transformative Therapies for Autoimmune DiseasesNuvig Therapeutics is pioneering novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are designed to be active for a wide range of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with existing therapies.Director, Regulatory...

  • Regulatory Affairs Director

    4 weeks ago

    Redwood City, California, United States Revolution Medicines Full time

    Revolution Medicines: A Leader in Precision OncologyWe are seeking an experienced Associate Director of Regulatory Affairs to join our team at Revolution Medicines, a clinical-stage precision oncology company dedicated to developing novel targeted therapies for RAS-addicted cancers.The OpportunityAs a key member of our Regulatory Affairs team, you will...

  • Regulatory Affairs Director

    4 weeks ago

    Redwood City, California, United States Work In Biotech Full time

    Transformative Opportunity in Regulatory AffairsNuvig Therapeutics is seeking a highly experienced Director, Regulatory Affairs to join our dynamic team. As a key member of our regulatory affairs department, you will be responsible for developing and implementing global regulatory strategies to support our investigational studies. This is an exciting...

  • Regulatory Affairs Director

    2 months ago

    Redwood City, California, United States HealthCare Recruiters International Full time

    About the ClientOur client is a pioneering company in the field of robotic systems for medical diagnosis and treatment, with a focus on advanced surgical interventions for complex conditions.Job SummaryWe are seeking a highly qualified Director of Regulatory Affairs to join our dynamic R&D team. This role is critical in driving the development of innovative...

  • Regulatory Affairs Manager

    3 weeks ago

    Redwood City, California, United States Corcept Therapeutics Full time

    At Corcept Therapeutics, we are dedicated to advancing the possibilities of cortisol modulation as a way to treat serious diseases.This role is responsible for partnering with Regulatory Affairs leaders to obtain and maintain regulatory filings and registrations for domestic and international regions.The Sr. Manager will coordinate activities with internal...

  • Senior Director Regulatory Affairs

    4 weeks ago

    Redwood City, California, United States Corcept Therapeutics Full time

    Job Title: Senior Director Regulatory AffairsCorcept Therapeutics is a leading biopharmaceutical company dedicated to the research and development of cortisol modulators. We are seeking a highly experienced Senior Director Regulatory Affairs to join our team and support the commercialization of our late-stage programs.Key Responsibilities:Develop and...

  • Senior Director Regulatory Affairs

    4 weeks ago

    Redwood City, California, United States Corcept Therapeutics Full time

    Job Title: Senior Director Regulatory AffairsCorcept Therapeutics is a leading biopharmaceutical company dedicated to the research and development of cortisol modulators. We are seeking a highly experienced Senior Director Regulatory Affairs to support the commercialization of our late-stage programs.Key Responsibilities:Develop and implement regulatory...

  • Regulatory Affairs Director

    3 weeks ago

    Redwood City, California, United States Retro Full time

    Regulatory Affairs DirectorRetro is seeking a highly skilled Regulatory Affairs Director to lead our regulatory efforts and help get our therapeutics from pre-IND to first-in-human clinical trial. As a key member of our team, you will oversee and advance the lifecycle of all of Retro's therapeutics, acting as the bridge between our internal research and...

  • Regulatory Affairs Senior Manager

    3 weeks ago

    Redwood City, California, United States REVOLUTION Medicines Full time

    At Revolution Medicines, we are committed to developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.The Senior Manager of Regulatory Affairs will play a crucial role in providing project teams with regulatory advice, managing and coordinating various Regulatory Affairs activities within and between departments, and obtaining...

  • Regulatory Affairs Senior Associate

    3 weeks ago

    Redwood City, California, United States REVOLUTION Medicines Full time

    At Revolution Medicines, we are committed to developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. As a Senior Associate, Regulatory Affairs, you will play a crucial role in supporting our team in day-to-day operational aspects of the department and interacting with global regulatory authorities.The Opportunity: This...

  • Senior Director, Clinical Regulatory Affairs Specialist

    3 weeks ago

    Redwood City, California, United States Arcellx, Inc. Full time

    Arcellx, Inc. is a pioneering biotechnology company dedicated to revolutionizing cell therapy for patients with cancer and other incurable diseases.We are committed to advancing humanity by developing cell therapies that are safer, more effective, and more accessible.As our Senior Director, Clinical Regulatory Affairs, you will play a critical role in...

  • Regulatory Affairs Data Entry Specialist

    3 weeks ago

    Foster City, California, United States LanceSoft Full time

    Job Title: CMC Regulatory Affairs Data Entry SpecialistJob Summary: We are seeking a highly detail-oriented and organized Regulatory Affairs Data Entry Specialist to join our team at LanceSoft. The successful candidate will be responsible for performing data entry using Gilead RIM System to enter relevant information to support key CMC RA stakeholders. The...

  • Regulatory Affairs Specialist

    4 weeks ago

    Foster City, California, United States Innova Solutions Full time

    Job DescriptionInnova Solutions is seeking a highly skilled Regulatory Affairs Assistant - II to join our team. As a key member of our Regulatory Affairs team, you will be responsible for performing data entry using our Client RIM System to support key CMC RA stakeholders.Key Responsibilities:Perform data entry using Client RIM System to enter relevant...

  • Senior Manager of Regulatory Affairs

    4 weeks ago

    Redwood City, California, United States REVOLUTION Medicines Full time

    Revolution MedicinesRevolution Medicines is a clinical-stage precision oncology company dedicated to developing innovative targeted therapies for RAS-addicted cancers. Our research pipeline focuses on RAS(ON) Inhibitors and RAS Companion Inhibitors, designed to suppress diverse oncogenic variants of RAS proteins.The OpportunityWe are seeking a highly skilled...

  • Senior Director Clinical Regulatory Affairs

    4 weeks ago

    Redwood City, California, United States Arcellx, Inc. Full time

    About ArcellxArcellx is a clinical-stage biotechnology company reimagining cell therapy by developing innovative immunotherapies for patients with cancer and other incurable diseases. Our mission is to destroy cancer and advance humanity by creating cell therapies that are safer, more effective, and more accessible.Job SummaryWe are seeking a Senior...

  • Senior Director Clinical Regulatory Affairs

    2 months ago

    Redwood City, California, United States Arcellx, Inc. Full time

    About Arcellx, Inc.Arcellx, Inc. is a pioneering biotechnology company dedicated to revolutionizing cell therapy for patients with cancer and other incurable diseases. Our mission is to develop innovative immunotherapies that are safer, more effective, and more accessible.Job Title: Senior Director, Clinical Regulatory AffairsWe are seeking an exceptional...

  • Regulatory Affairs Specialist

    4 weeks ago

    Foster City, California, United States Innova Solutions Full time

    Job Description:As a Regulatory Affairs Assistant - II, you will be responsible for performing data entry using the Client RIM System to support key CMC RA stakeholders. You will work collaboratively with the team to execute routine data entry, such as inputting submission-related dates and regulatory assessment comments. Your tasks will include ensuring the...

Regulatory Affairs Specialist

2 months ago

Redwood City, California, United States REVOLUTION Medicines Full time
Revolution Medicines: A Leader in Precision Oncology

Revolution Medicines is a clinical-stage precision oncology company dedicated to developing innovative targeted therapies to combat RAS-addicted cancers. Our research pipeline focuses on RAS(ON) Inhibitors and RAS Companion Inhibitors, designed to suppress diverse oncogenic variants of RAS proteins and enhance combination treatment strategies.

The Opportunity

The Senior Associate, Regulatory Affairs will play a crucial role in supporting Senior Regulatory Affairs management in the day-to-day operations of the department. This position will also interact with global regulatory authorities, represent Regulatory Affairs on project teams, and collaborate with multidisciplinary teams to identify submission requirements and coordinate the content and development process of regulatory documentation.

Key Responsibilities
  • Compile regulatory submissions that meet ICH or FDA requirements, local or regional regulatory requirements, and company policies and procedures.
  • Prepare and manage routine submissions and related activities, defining and managing detailed timelines to ensure timely delivery of high-quality, compliant, accurate, and complete regulatory submissions.
  • Assist in the development and implementation of SOPs and systems to track and manage product-associated events.
  • Investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context to assist in assessment of regulatory implications for development and approval.
  • Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
  • Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects.
  • Work with manager on acquisition and development of required regulatory skills and knowledge.
Requirements
  • Bachelor's degree in a relevant field.
  • Two or more years prior experience in a Regulatory Affairs department at a drug or biologics company.
  • Some familiarity with regulatory requirements for development of drug and biological products, including FDA regulations and guidance, and ICH guidelines.
  • Willing to advance knowledge of regulatory practice through classes, certifications, webinars.
  • Technical expertise with Windows, MS Office (Outlook, Word, Excel), Adobe Acrobat software systems, and experience working in an electronic document management system.
Preferred Skills
  • Experience in oncology drug development.
  • Experience with supporting the preparation and submission of large complex regulatory submissions, including NDA's.
  • Excellent written and verbal communication skills.
Compensation and Benefits

The base salary range for this full-time position is $95,000 to $120,000 for candidates based at our headquarters in Redwood City, CA. 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.