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Life Science People
San Francisco, CA, United States
LSP is partnering with a biotech client of ours seeking a Vice President of Regulatory Affairs with a strong background in Neurology + Regulatory Affairs to join their team in the South San Francisco area. Requirements Extensive background with Regulatory Affairs, specifically with Neurology Combination experience Small molecule experience ideal St
Job Source: Life Science PeopleTempest Therapeutics
Brisbane, CA, United States
SUMMARY AND SCOPE: We are seeking a strategic and results-oriented leader to oversee all regulatory activities for our immuno-oncology pipelines, with an initial focus on the upcoming Phase 3 clinical trial for our lead candidate, Amezalpat (TPST-1120). You will be responsible for developing and implementing comprehensive regulatory strategies to e
Job Source: Tempest TherapeuticsConfidential
San Francisco, CA, United States
Vice President Regulatory Affairs About the Company Globally recognized telecommunications & technology company Industry Telecommunications Type Public Company Founded 1865 Employees 10,001+ Categories Information Technology & Services Networking Technology Telecommunications Hardware Telecom Hardware Telephones Wireless Phones Specialties Telec
Job Source: ConfidentialDennis Partners
San Francisco, CA, United States
This clinical-stage biotech company is revolutionizing the treatment of cancer. They are seeking a Vice President of Regulatory Affairs to oversee all regulatory activities including serving as the primary contact with FDA and other regulatory agencies. You will develop and implement regulatory strategies, lead Health Authority interactions, and ov
Job Source: Dennis PartnersConfidential
San Francisco, CA, United States
Vice President, Legal & Regulatory Affairs About the Company Premier provider of life science tools Industry Biotechnology Type Public Company Founded 1998 Employees 5001-10,000 Categories Biotechnology Genetics Medical Consulting & Professional Services Biochemistry and Molecular Biology Bioinformatics Biology Gene Expression Health Care Healthcar
Job Source: ConfidentialTempest Therapeutics
Brisbane, CA, United States
SUMMARY AND SCOPE: We are seeking a strategic and results-oriented leader to oversee all regulatory activities for our immuno-oncology pipelines, with an initial focus on the upcoming Phase 3 clinical trial for our lead candidate, Amezalpat (TPST-1120). You will be responsible for developing and implementing comprehensive regulatory strategies to e
Job Source: Tempest TherapeuticsTempest Therapeutics
South San Francisco, CA, United States
Vice President, Regulatory Affairs Reports To: Chief Medical Officer and Head of R&D Department: Regulatory Department Head: Chief Medical Officer and Head of R&D Location: Brisbane, CA Summary and Scope: We are seeking a strategic and results-oriented leader to oversee all regulatory activities for our immuno-oncology pipelines, with an init
Job Source: Tempest TherapeuticsPremier Research
San Francisco, CA, United States
Back to Careers Premier Consulting, a division of Premier Research, is seeking a Senior Vice President, Regulatory Affairs. Become a part of a strategic product development and global regulatory consulting company dedicated to helping biotech and medtech innovators transform their life-changing ideas and breakthrough science into new medical tre
Job Source: Premier ResearchSan Francisco, CA, United States
VP/SVP Regulatory Affairs
Location: San Francisco, CA
6-12 month-intital contract
Key Responsibilities:
Develop and execute global regulatory strategies across nonclinical, clinical, quality, and CMC functions ensuring alignment with corporate objectives/timelines and regulatory compliance.
Provide advice and guidance to project teams on the interpretation and application of relevant regulatory guidances and requirements, and review processes.
Present regulatory strategies and issues at team and governance meetings.
Play a key role in planning, preparation, drafting, and review of regulatory documentation, including IND/CTA/GMO/BLA/MAA submissions, regulatory interactions, and responses to queries from competent authorities as required for the investigation and registration of drugs in the US and ex-US countries.
Serve as the primary health authority contact for assigned projects and foster positive and effective working relationships between project team members and health authority reviewers.
Collaborate cross-functionally with nonclinical, CMC, and quality leadership and stakeholders on planning and coordinating regulatory submissions and interactions with health authorities.
Prepare teams for and lead health authority meetings.
Manage and participate in the creation, review, assembly, and submission of regulatory documentation, including INDs, CTAs, and amendments, and annual reports.
Ensure consistency, completeness, and adherence to standards for all regulatory submissions.
Provide regulatory review and impact/implementation assessment of proposed Change Control records and manage the associated regulatory notifications.
Required Skills and Background:
Minimum 12 years of relevant regulatory leadership experience in the biotech and pharmaceutical industry
Proven track record supporting CTD format and content for regulatory filings (e.g., INDs, CTAs, NDAs/BLAs).
Experience in establishing regulatory capabilities and functions.
Demonstrated ability to develop and maintain excellent working relationships with EU regulatory agencies, US FDA, and similar key international regulatory agencies, including the planning/implementation of agency meetings.
Excellent interpersonal communication and presentation skills to facilitate collaboration across functions and build successful relationships with internal and external stakeholders, as well as external parties.
Experience managing complex schedules and shifting priorities in a dynamic environment.
Ability to dissect complex issues in the gene editing and gene therapy field and quickly distill key items for discussion with regulatory authorities and guide teams in the preparation of responses to regulatory questions.
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Email Alert for Vice President Regulatory Affairs jobs in San Francisco, CA, United States
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