Senior Director, Regulatory Affairs DICE
3 weeks ago
Be accountable for leading the development of strategic plans for pipeline assets and implementation.
Provides leadership on project teams in all areas of regulatory affairs
Develop regulatory strategies across multiple regulatory activities (CMC, nonclinical, and clinical) to ensure timelines and achievements are met to support the business needs of the company
Plan, implement, and lead successful regulatory agency meetings and interactions per regulatory strategy
Define content for and direct the organization and preparation of high quality and effective regulatory submissions, including future applications (e.g., CTA and IND)
Review and approve clinical study protocols, informed consent forms, statistical analysis plans, clinical study reports, investigator brochures, responses to regulatory agencies and all regulatory submissions
Serve as regulatory liaison with global health authorities, business partners, and CROs
Play a key role as a member of the Development Leadership Team
Understands and maintain knowledge and monitor changes in pertinent laws, regulations and guidance’s and takes a leadership role in assessing and communicating the impact of these requirements to the business
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Senior Director, Regulatory Affairs DICE
4 days ago
San Francisco, CA, United States Advance Global Professionals Inc. Full timeBe accountable for leading the development of strategic plans for pipeline assets and implementation. Provides leadership on project teams in all areas of regulatory affairs Develop regulatory strategies across multiple regulatory activities (CMC, nonclinical, and clinical) to ensure timelines and achievements are met to support the business needs of the...
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Regulatory Affairs Director
1 month ago
San Francisco, United States BioLink 360 Full timeCompany Location: Bay Area Comp: 150K-220K Position Reports to: VP of Regulatory and Quality Director of Regulatory Affairs -San Francisco We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help develop &...
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Senior/Executive Director Regulatory Affairs
3 days ago
San Francisco, United States EPM Scientific Full timeJob DescriptionJob DescriptionTitle: Senior/Executive Director Regulatory AffairsSummary: A growing immune-oncology company is seeking a Senior/Executive Director of Regulatory Affairs to join the team in executing regulatory strategies and supporting the development of their product pipeline with an emphasis on early stage development.The S/E Director of...
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Director, Regulatory Affairs
3 weeks ago
South San Francisco, United States Maze Therapeutics Full timeThe Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you will...
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Director, Regulatory Affairs
3 weeks ago
South San Francisco, United States Maze Therapeutics Full timeJob DescriptionJob DescriptionThe Position:Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global...
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Director, Regulatory Affairs
4 weeks ago
South San Francisco, United States Maze Therapeutics Full timeJob DescriptionJob DescriptionThe Position:Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global...
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Regulatory Affairs Associate
5 days ago
South San Francisco, United States Cytokinetics Full timeReporting to the Senior Director of Regulatory Affairs, the Regulatory Affairs Associate is responsible for coordination and preparation of a variety of regulatory submissions and for assisting the Regulatory Affairs team with various projects. **Responsibilities** - Prepare and/or coordinate and comply routine regulatory submissions and other...
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San Francisco, United States BioLink 360 Full timeSenior Regulatory Affairs Specialist-Remote Based-West Coast Description Reports to: Global Regulatory Affairs Director Salary Range: 140-170K Location: Remote Based Travel: Occasional travel to West Coast, Must reside in Pacific or Mountain time zone This Senior Regulatory Affairs Specialist will have an opportunity to work on new to market technology that...
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Regulatory Affairs Director, Oncology
1 week ago
South San Francisco, United States AstraZeneca, plc Full timeWithin Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet needs. We work across our ground-breaking pipeline and the business to get medicines to patients as efficiently and optimally as po Regulatory Affairs, Director, Oncology, Regulatory, Leadership, Strategy, Business Services
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San Diego, United States Ignite Human Capital Full timeJob DescriptionJob DescriptionCompany Overview:Based in San Diego, CA, our client is dedicated to enhancing the lives of patients and families by developing safe, highly effective, and accessible allogeneic NK and macrophage cell therapies for the treatment of various serious diseases, including cancer. Join our dynamic team and be part of the transformative...
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San Diego, United States Ignite Human Capital Full timeJob DescriptionJob DescriptionCompany Overview:Based in San Diego, CA, our client is dedicated to enhancing the lives of patients and families by developing safe, highly effective, and accessible allogeneic NK and macrophage cell therapies for the treatment of various serious diseases, including cancer. Join our dynamic team and be part of the transformative...
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Senior Director, CMC Regulatory Affairs
1 month ago
South San Francisco, United States Allogene Therapeutics Full timeJob Description About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is...
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Senior Director Regulatory Affairs
4 days ago
San Francisco, CA, United States Life Science People Full timeRegulatory Leadership: Provide regulatory guidance to project teams, collaborating with cross-functional members and external partners to devise effective strategies. Lead teams in evaluating strategy options, identifying and mitigating regulatory risks, and guiding successful regulatory interactions. Requirements: Bachelor’s degree in life sciences;...
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VP Regulatory Affairs
3 days ago
San Francisco, United States People With Chemistry Full timeJob Title: Head of Regulatory Affairs - Biologics and DermatologyCompany Overview: Join a leading biopharmaceutical company at the forefront of innovation in biologics and dermatology. Our client is committed to developing transformative therapies that address unmet medical needs and improve the lives of patients globally. Their is dedicated to pushing the...
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Quality & Regulatory Affairs Director
4 days ago
San Jose, CA, United States Meet Recruitment Limited Full timeMy client is a clinical-stage biopharmaceutical company focused on developing innovative therapies for rare diseases. They are currently seeking a skilled regulatory professional to join their growing team as Director/ Sr. Director CMC Regulatory Affairs. This role will involve hands-on development and implementation of regulatory strategies for CMC aspects...
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Director of Regulatory Strategy
4 days ago
San Francisco, CA, United States Cypress HCM Full timeThe role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and ensure...
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VP, International Regulatory Affairs
4 days ago
San Diego, CA, United States Device Search Group Full timeWe are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background in cell therapy with experience in early development regulatory affairs (pre-IND...
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Global Director of Regulatory Affairs
1 week ago
South San Francisco, United States Remegen Biosciences, Inc. Full timeJob DescriptionJob DescriptionORGANIZATIONRemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein...
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Global Director of Regulatory Affairs
2 days ago
South San Francisco, United States Remegen Biosciences, Inc. Full timeJob DescriptionJob DescriptionORGANIZATIONRemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein...
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Sr Manager/AD Regulatory Affairs
1 week ago
San Francisco, California, United States Nurix Therapeutics Full timeResponsibilities and Duties:Responsible for timely planning, coordination, and execution of regulatory submissions to FDA and other jurisdictionsOversee the authoring, review, approval and submission of Clinical, Nonclinical, and CMC documents for regulatory submissionsConduct regulatory review of submission documentsCoordinate with external publishing...