Senior Associate, Regulatory Affairs
3 weeks ago
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 developing a pipeline of off-the-shelf CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on X (formerly Twitter) and LinkedIn. About the role: The Senior Associate will support all aspects of regulatory affairs related to the development of novel CAR T therapies including quality, preclinical and clinical areas of drug development. Responsibilities include: Assist in the authoring, submission, and maintenance of global regulatory submissions related to clinical, CMC and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigators Brochure. Assist in coordination and preparation for Agency meetings and associated briefing documents. Collaborates with subject matter experts to provide written responses to queries. Leads and tracks queries and commitments with regulatory agencies and helps maintain commitment tracker and Health Authority questions database. Provide representation for study-level regulatory activities at study management teams. Author Cover Letters, Form FDA 1571, and other administrative documents to support routine submissions to FDA. Assist interactions with publishing vendor to support timely delivery of final documents for electronic publishing. Conduct regulatory intelligence projects as assigned to support clinical strategy decisions. Assist in authoring of Standard Operating Procedures. Requirements: Bachelors degree preferred in the sciences, or health related field. Interest in building a career in Regulatory Affairs. Strong knowledge of eCTD elements and structure including CMC. Ability to work in a fast-paced, start-up environment. Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines. Ability to work independently and as part of a team to drive for results. Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment. Candidates must be authorized to work in the U.S. We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $110,000 to $140,000. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law. As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients. #LI-EL1
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Regulatory Affairs Associate
4 weeks 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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Regulatory Affairs Associate
2 hours 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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Senior Associate, Regulatory Affairs
4 weeks 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 Associate, Regulatory Affairs
3 weeks 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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Associate Director, Regulatory Affairs
2 weeks ago
South San Francisco, United States Cytokinetics Full timeReporting to the Senior Director, Regulatory Affairs, the Associate Director of Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies. **Responsibilities** - Formulate regulatory strategies, with supervisor oversight, based on current...
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Regulatory Affairs Associate
7 days ago
South San Francisco, California, United States Cytokinetics Full timePrepare and/or coordinate and comply routine regulatory submissions and other correspondence in accordance with regulatory agency regulations and guidelines Review regulatory documents to ensure that all submissions are complete, accurate and meet re Regulatory Affairs, Regulatory, Associate, Business Services
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Senior Manager, Regulatory Affairs
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South San Francisco, California, United States Cytokinetics Full timeFormulate regulatory strategies, with supervisor oversight, based on current regulatory intelligence Collaborate with cross-functional project teams and external business partners to develop regulatory strategies, identify regulatory risks and provid Regulatory Affairs, Manager, Regulatory, Senior, Business Partner, Business Services
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Regulatory Affairs CMC Associate
4 weeks ago
San Mateo, United States Fladger Assoc. Inc. Full timeJob Description Job Description Foster City, CA Contract Duration: 6-18 months Rate: Negotiable Responsibilities: Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLY Provide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of...
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Regulatory Affairs CMC Associate
2 months ago
San Mateo, United States Fladger Assoc. Inc. Full timeJob DescriptionJob DescriptionFoster City, CAContract Duration: 6-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLYProvide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology,...
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Regulatory Affairs CMC Associate
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San Mateo, United States Fladger Assoc. Inc. Full timeJob DescriptionJob DescriptionFoster City, CAContract Duration: 6-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLYProvide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology,...
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Regulatory Affairs CMC Associate
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Director, Regulatory Affairs
2 months ago
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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
2 months 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
2 months 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
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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Regulatory Affairs Director
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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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Associate Director, Regulatory Affairs Cmc
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South San Francisco, United States ALX Oncology Inc. Full timeWe are looking for an** Associate Director/Director, Regulatory Affairs CMC **to join our team. **Responsibilities**: These include but are not limited to: - Providing dynamic regulatory leadership to project teams and working collaboratively with cross-functional team members and external contractors/vendors/consultants to identify optimum and workable...
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Senior/Executive Director Regulatory Affairs
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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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Regulatory Affairs Associate
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San Mateo, United States Fladger Assoc. Inc. Full timeJob DescriptionJob DescriptionFoster City, CAContract Duration: 12-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Regulatory Affairs Associate II in the Foster City, CA area. (Onsite Role)Contractor must meet the company site requirements for the COVID Vaccination PRIOR to starting roleResponsible for the preparation of Drug...