Vice President, Regulatory Affairs and Quality ...

Vice President, Regulatory Affairs and Quality AssuranceTerns Pharmaceuticals, Inc. (NASDAQ: TERN) is a clinical-stage biopharmaceutical company developing a portfolio of small molecule product candidates to address serious diseases, including oncology and obesity. Terns' pipeline includes three clinical-stage development programs - an allosteric BCR-ABL inhibitor for CML, a small molecule GLP-1 receptor agonist, and a THR-β agonist - as well as a preclinical GIPR modulator program.Who We Are Looking ForIncrease your chances of reaching the interview stage by reading the complete job description and applying promptly.The Vice President, Regulatory Affairs and Quality Assurance, will lead the regulatory and quality functions for all development-stage programs. This role will focus on developing and executing regulatory strategies, managing global health authority interactions, and overseeing quality operations to ensure compliance and successful progression through clinical development and approval processes. As a member of the Senior Leadership Team, the VP will work closely with internal teams and external partners to ensure regulatory milestones are met while maintaining the highest quality standards across all projects.What You'll DoLead global regulatory strategy development for small-molecule product candidates in oncology and obesity.Manage interactions with FDA, EMA, and other global health authorities to ensure regulatory milestones are met.Oversee regulatory submissions, including INDs, NDAs, and MAAs, ensuring compliance with global standards.Provide strategic leadership of the quality team and collaborate with the existing QMS personnel to maintain compliance with regulatory standards (FDA, ICH, EMA).Work cross-functionally with clinical, manufacturing, and non-clinical teams to ensure alignment between regulatory and quality efforts and corporate goals.Manage and lead the regulatory and quality teams, ensuring cohesive execution of regulatory and quality strategies.Stay current with evolving regulatory requirements and provide guidance on regulatory and quality compliance, particularly in oncology and obesity.Contribute to the development of corporate strategy, ensuring regulatory and quality perspectives are integrated into decision-making processes.What You'll Bring to Our Team:A people-first mindset with a collaborative approach to problem-solving.Strong leadership skills with the ability to manage regulatory and quality functions in a fast-paced, dynamic environment.10+ years of regulatory experience in the pharmaceutical or biotechnology industry, with a focus on small molecules.Proven success managing regulatory interactions with FDA, EMA, and other global health authorities.Experience overseeing quality systems in a regulatory capacity, with strong understanding of compliance standards (FDA, ICH, EMA).Demonstrated success in regulatory submissions, including IND, NDA, and MAA filings.Experience in oncology and/or obesity therapeutic areas is highly desirable.Bachelor's degree in a science-related field is required; an advanced degree is preferred.The expected base pay for this full-time position is $280,000 - $325,000 + bonus + equity + benefits. At Terns, our salary ranges are determined by role, level, and location. The ranges are subject to change and individual pay within that range can vary for several reasons including location, skills/capabilities, experience, and available budget.Terns Pharmaceuticals is committed to being an Equal Opportunity Employer and our policy is to provide equal employment opportunities to all applicants and employees without regard to race, color, creed, religion, sex, sexual orientation, gender identity, marital status, citizenship status, age, national origin, ancestry, disability, veteran status, or any other legally protected status and to affirmatively seek to advance the principles of equal employment opportunity.#J-18808-Ljbffr

Created: 2024-11-14