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Alector
South San Francisco, CA, United States
Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare in
Job Source: AlectorCytokinetics
South San Francisco, CA, United States
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mecha
Job Source: CytokineticsAbbott Laboratories company
Santa Clara, CA, United States
Working at Abbott. At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youll also have access to:Career development with an international company where you can grow the care Regulatory Affairs, Director, Regulatory, Associate, Product Development, Healthcare, Business Servi
Job Source: Abbott Laboratories companyBD
Milpitas, CA, United States
Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions o
Job Source: BDAbbott
Santa Clara, CA, United States
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Job Source: AbbottCytokinetics
South San Francisco, CA, United States
Reporting to the Senior Director of Regulatory Affairs, the Senior Manager, Regulatory Affairs is responsible for coordination and preparation of a variety of regulatory submissions and for assisting the Regulatory Affairs team with various projects. Responsibilities Formulate regulatory strategies, with supervisor oversight, based on current reg
Job Source: CytokineticsAlector
South San Francisco, CA, United States
Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare in
Job Source: AlectorAscendis Pharma
Palo Alto, CA, United States
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues. Guided by our core
Job Source: Ascendis PharmaRedwood City, CA, United States
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:
The Associate Director of Regulatory Affairs will independently represent regulatory affairs on cross-functional teams and provide targeted, actionable advice across the clinical development organization. The candidate must have a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking and be able to provide clear and concise feedback to management and project teams, facilitate decision-making and provide effective leadership to ensure successful regulatory outcomes.
Demonstrate leadership within the regulatory affairs department and cross-functionally to help develop, implement, and maintain initiatives, processes, and procedures with a recognition of when to consult departmental senior concerning risks.
Independently plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence.
Help drive operational decision making and planning within the department, overseeing workflow, assignments, and staff development with minimal direction.
Utilize a comprehensive knowledge of regulations, regulatory authorities' guidance, and industry practices to support organizational objectives.
Able to proactively identify risks and devise mitigation strategies.
Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams.
Perform regulatory research to inform business strategy. Assess and communicate risks.
Assure that there are no significant interruptions to the business due to regulatory compliance issues.
Collaborates across the organization at all levels, across functional groups, and with executive management.
Develop regulatory strategies to inform associated budgets, tools and specialized support necessary for efficient operations.
Required Skills, Experience and Education:
Bachelor's Degree in a relevant field, an advanced degree is desirable, with a minimum of 7 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 5 years in Regulatory Affairs.
Experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities.
Experienced in representing Regulatory Affairs on cross functional teams and presenting to senior management. Excellent communicator.
Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
Strong working knowledge of US FDA and EU EMA Pharmaceutical regulations and guidance. Experience with EU CTR submissions preferred.
Preferred Skillset:
Direct experience with oncology drug development highly preferred.
Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols highly preferred.
Direct experience with FDA expedited programs highly preferred.
The expected salary range for this role is $160,000 to $200,000. An individual's position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. 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 [email protected].
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Email Alert for Associate Director, Regulatory Affairs jobs in Redwood City, CA, United States
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