South San Francisco, California, United States · On-site
$161k–$305k/yr
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: Global Regulatory Strategy, Oncology Drug Development, Health Authority Interaction, Project Management, Regulatory Submissions
South San Francisco, California, United States · Hybrid
$80/hr–$93/hr
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South San Francisco, California, United States · On-site
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South San Francisco, California, United States · On-site
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South San Francisco, California, United States · Hybrid
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The Position We are seeking a detail-oriented Scientist to work in the Non-Clinical Development department overseeing bioanalytical work for Maze. In this role, you will oversee bioanalysis for Good Laboratory Practices …
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South San Francisco, California, United States · On-site
$90k–$112k/yr
Natera is seeking a skilled and motivated Associate Scientist to join the R&D Platform team, focusing on building scalable assays to advance our product portfolio. The ideal candidate will possess hands-on experience wit…
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South San Francisco, California, United States · Hybrid
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Skills: Python, JAX, PyTorch, Machine Learning Engineering, Model Optimization
South San Francisco, California, United States · On-site
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South San Francisco, California, United States · On-site
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The Department of Cell and Tissue Genomics is seeking a creative, rigorous, and motivated Scientist 3 to execute cutting-edge single-cell and functional genomic techniques to study cancer biology. The successful candidat…
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South San Francisco, California, United States · On-site
$70/hr
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South San Francisco, California, United States · Hybrid
$276k–$322k/yr
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients…
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South San Francisco, California, United States · On-site
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Career CategoryScientificJob DescriptionJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious …
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South San Francisco, California, United States · On-site
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South San Francisco, California, United States · On-site
$89k–$140k/yr
Job Description Position Description: The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) organization at our company's Research Laboratories is seeking a highly motivated and collaborative scientist to j…
Skills: Mammalian Cell Culture, Cell-Based Assays, Biologics Bioanalytical Experimentation, Ligand Binding Assays, FACS
South San Francisco, California, United States · Hybrid
$276k–$322k/yr
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients…
Skills: Clinical Development Planning, Protocol Design, Medical Monitoring, Regulatory Interactions, Cardiology
South San Francisco, California, United States · On-site
$175k–$190k/yr
At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at Veracyte enables our employees…
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South San Francisco, California, United States · On-site
$211k–$401k/yr
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: Clinical Trial Design, Clinical Development Planning, Regulatory Compliance, Pharmacovigilance, Good Clinical Practices
South San Francisco, California, United States · On-site
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Skills: Patient Examination, Diagnostic Testing, Suturing, Wound Care, Patient Management
South San Francisco, California, United States · On-site
$70k–$95k/yr
Company info NewLimit is a biotechnology company working to radically extend human healthspan. We’re developing medicines to treat age-related diseases by reprogramming the epigenome, a new therapeutic mechanism to resto…
Skills: Laboratory Operations, Inventory Management, Equipment Maintenance, Vivarium Management, Animal Husbandry
South San Francisco, California, United States · On-site
$100k–$107k/yr
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more t…
Skills: High-Plex Imaging, Computational Image Analysis, Machine Learning, Python, Single-Cell Genomics
South San Francisco, California, United States • On-site
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The Director serves as the Global Regulatory Lead, developing and implementing regulatory strategies for multiple oncology early development assets. They lead the Global Regulatory Product Team and act as the primary interface with global health authorities to ensure compliance and accelerate drug development.
Requires a bachelor's degree in life sciences or chemistry and at least 5 years of regulatory affairs experience, preferably in oncology or cell and gene therapy. Candidates must have international regulatory experience and a proven track record of strategic leadership in complex matrix environments.
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of both marketed products and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.
AbbVie is focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work to combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments.
We are currently seeking a Regulatory Affairs Director to join our growing regulatory team. In this role you will be the Global Regulatory Lead where you will develop and implement global regulatory strategies to support the development of multiple oncology early development assets, contributing to the advancement of leading edge cancer research in a nimble, biotech –like environment within a large, well established pharmaceutical company.
The Director Regulatory Affairs Global Regulatory Lead in OED RA is responsible for developing and implementing global regulatory strategies to support the development of multiple oncology early development assets, contributing to the advancement of leading-edge cancer research in a nimble, biotech –like environment within a large, well established pharmaceutical company.
The GRL leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. Serves as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Demonstrates strong understanding of drug development and leadership behaviors consistent with level. Develop and implement acceleration strategies with guidance from supervisor.
This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables.
Key Responsibilities:
· Serve as the Global Regulatory Lead on project teams and key sub-teams
· Develop and implement competitive and effective global regulatory strategies for several products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies
· Provide advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and review processes
· Collaborate with AbbVie regional and country regulatory affiliates to support ex-US clinical development activities
· Present Regulatory strategies and issues at team and governance meetings
· Serve as primary Health Authority contact for assigned projects and foster positive and effective working relationships between project team members and Health Authority reviewers
· Prepare teams for and lead FDA and other Health Authority meetings
· Manage and participate in the creation, review, assembly and submission of regulatory documentation including clinical trial applications and amendments to these regulatory files, as appropriate
· Ensure consistency/completeness/adherence to standards for all regulatory submissions
· Coordinate and consult with other departments on the content, review of publication materials, and assembly of regulatory documentation
· Support non-program specific projects assigned such as department initiatives, business development assessments, clinical assessments and department training, etc.
· Required education: Bachelor degree in life sciences, chemistry, or related discipline.
· Preferred Education: Relevant Advanced degree preferred. Certification a plus.
· 5+ years of experience in Regulatory Affairs (strong preference for experience in oncology and/or cell and gene therapy) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment. International regulatory experience required. Some portion may include relevant exposure to pharmaceutical regulatory work (e.g., other R&D role or specialized training).
· Proven success in a strategic leadership role with strong project management skills. Experience working in a complex and matrix environment, and with multiple stakeholders. Demonstrated leadership ability in team settings
· Experience interfacing with government regulatory agencies.
· Demonstrated understanding of regulations and guidelines governing drug development and ability to apply these to overall strategic drug development
· Strong written and verbal communication and negotiation skills
· Demonstrated Business acumen and able to work under pressure
· Demonstrated expertise and knowledge of oncology
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Allergan is now part of AbbVie. AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on LinkedIn for future updates.
Offices: Allergan plc, Dublin, Coolock D17 E400, IE · Morris Corporate Center III, 400 Interpace Parkway, Parsippany, NJ 07054, US · Parkway, Marlow, England SL7 1YL, GB · 301 W Howard Ln, Austin, TX 78753, US · 8301 Mars Dr, Hewitt, TX 76712, US
Based on 324 listings with disclosed salaries, most science & research jobs in South San Francisco, CA pay between $108k–$272k per year. Individual offers vary with seniority, company size, and specialization.
There are currently 366 open science & research positions in South San Francisco, CA listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Roche, Allergan, Cytokinetics, MSD, Amgen, among others. Browse the listings above to see every active employer.
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