Regulatory Strategy Lead - Gene Therapy & ASO
Selby Jennings
EPM Scientific partners with an early-stage biotech building a personalized genetic medicine platform for rare diseases. The Regulatory Strategy Lead will work hands-on with the founder to shape development pathways for individualized programs and build the regulatory playbook from the ground up. This role requires strategic execution in an uncertain, entrepreneurial setting, including leadership of Pre-IND and IND interactions and translating science into actionable regulatory strategies that #J-18808-Ljbffr EPM Scientific
- Regulatory Strategy Lead - Gene Therapy / ASO I'm partnering with an early‑stage company building a new model for personalized genetic medicine in rare and ultra‑rare disease. The team is looking for a hands‑on regulatory strategist who can help shape early development...Regulatory
- Neurocrine Biosciences in San Diego seeks a Regulatory Affairs professional to drive regulatory strategy execution for development programs. You will collaborate... ...perspectives on cross‑functional teams. The role leads regulatory filings, guides global strategies for CMC...Regulatory
$132.7k - $182k
Neurocrine Biosciences is seeking an experienced professional in Regulatory Affairs based in San Diego, California. This role involves supporting regulatory strategy execution and preparing regulatory submissions including IND/CTA, NDA/BLA, and clinical research documentation...Regulatory$165k - $205k
...California is seeking an Associate Director of Microbiology to lead the microbiology function for revolutionary genomics... ...development. The ideal candidate will spearhead the microbiology strategy, ensuring regulatory compliance and quality standards across all...Regulatory- ...is seeking an experienced DMPK leader in San Diego to define the scientific strategy for Drug Metabolism & Pharmacokinetics. The role involves managing DMPK strategies, overseeing regulatory submissions, and collaborating with cross-functional teams. Candidates should...Regulatory
- ...readiness for change. Within SRCO, the SOX Strategy, Operations & Audit Excellence team is... .... Role Summary We're looking for a Lead, SOX Program Strategy & Audit Excellence... ...across the SRCO team. Monitor the evolving regulatory environment (PCAOB, SEC) and incorporate...RegulatoryWork experience placementWork at office
- A leading biopharmaceutical company in San Diego seeks an Executive Director of Regulatory Strategy for their Endocrinology pipeline. This role requires extensive experience in regulatory strategy, leadership, and developing cohesive roadmaps across diverse therapeutic...Regulatory
- ...effective and safer cellular therapies with ex vivo manipulation. Tulynode’s gene modification strategy and “Immuno-Pod” platform is... ...‑Modification Scientist will lead experimental design and execution... ...support preclinical studies, regulatory submissions, and future...RegulatoryFull time
$148.95k - $215.14k
...the Area Chief of Staff is to lead, develop and manage associate... ...a proactive retention strategy, and creating a culture of community... ...all local, state and federal regulatory requirements including but... ...building options. Digital Exercise Therapy: Stay active and healthy with...RegulatoryFull timeTemporary workPart timeLocal areaFlexible hoursShift work- ...caregivers, providers, and advocates. You will own organic social strategy, influencer partnerships, patient ambassador programs, and... ...communities to educate, engage, and build trust while meeting regulatory expectations. The role partners across Consumer Marketing, Clinical...Regulatory
$189k - $246k
...identify, develop and deliver life-changing therapies to people living with rare disease.... ...to pursue our vision of becoming a leading biopharmaceutical company dedicated... ....Position Summary:The Director, Regulatory Affairs Strategy is responsible for developing and executing...RegulatoryTemporary workLocal area- ...with contracts and performance standards. This role is pivotal in liaising between internal leadership and subcontractors, focused on delivery excellence and cost control. The position aims to uphold regulatory obligations and operational goals. #J-18808-Ljbffr MaximusRegulatoryFor subcontractor
- Travere Therapeutics is seeking a Manager for Regulatory Affairs to lead regulatory efforts for late-stage development programs in San Diego. This role involves close collaboration with cross-functional teams and is integral to the regulatory planning and submission process...RegulatoryRemote job
$116k - $151k
Department: 107000 Regulatory Location: San Diego, USA- Remote Be... ...develop and deliver life‑changing therapies to people living with rare... ...our vision of becoming a leading biopharmaceutical company... ...implementation of global regulatory strategies from development through...RegulatoryContract workTemporary workRemote work$200k - $230k
...natural killer (NK) cell‑based therapies. Our mission is to develop... ...in a community setting. Our lead product candidate, AlloNK®, is... ...Director, Corporate Development & Strategy is a senior, cross‑functional... ..., clinical development, regulatory, medical affairs, finance, and...RegulatoryFlexible hours- ...seeking a Principal Scientist I/II onsite in San Diego, CA to develop downstream purification processes for next-generation AAV gene therapy and to lead a 3-5 person downstream process team. You will collaborate with upstream, analytical, and development groups to advance...
$214k - $292k
...Role: The Senior Director Quality Assurance will lead Gene Therapy QA oversight for product programs from toxicology... ...partners. The role is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, evolving pipelines. This is...RegulatoryContract workWork at officeLocal areaFlexible hours3 days per week- Role, Inc. is seeking a Senior Manager, Medical Writing in San Diego. This position is responsible for authoring and managing regulatory documents, ensuring scientific accuracy and compliance while collaborating with cross-functional teams. The ideal candidate will have...Regulatory
- ...Executive Director, Regulatory Affairs About the Company... ...cell therapy autoimmune and lupus... ...executing global regulatory strategy to support the development... ...including the FDA, and will lead and support key regulatory... ...in cell and/or gene therapy, particularly in...Regulatory
- ...diseases by silencing the genes that cause them. Using... ...delivery, Arrowhead therapies trigger the RNA... ...biologics. Arrowhead is leading the field in bringing... ...comprehensive quality assurance strategy aligned with... ...compliance/alignment with regulatory requirements and internal...Regulatory
- ...diseases by silencing the genes that cause them. Using... ...delivery, Arrowhead therapies trigger the RNA... ...biologics. Arrowhead is leading the field in bringing... ...Position The Director of Regulatory Affairs is Arrowhead’s... ...global regulatory labeling strategy. This individual will...Regulatory
$232k - $284k
...team committed to developing therapies that make a meaningful difference... ...Director, Regional Ecosystem Lead (San Diego)? The job is... ...opportunities aligned with all TA strategies and portfolio priorities.... ...protein technology, and cell and gene therapy to support continued...Local areaRemote workWorldwide- ...cell and exosome-based therapies for rare diseases. At... ...Deramiocel (CAP-1002), our lead cell therapy in late-... ..., and sampling strategies aligned with risk and... ...and host/liaise during regulatory inspections (e.g., FDA... ...to biologics, cell & gene therapy, aseptic processing...Regulatory
- Role, Inc. is seeking a Senior Manager for CMC Regulatory Affairs in San Diego, focusing on global regulatory strategies to support biologics development, particularly in rare disease therapeutics. This role requires extensive experience in Regulatory Affairs, with a focus...RegulatoryRemote job
$88.5k - $113.55k
...a provider of evidence-based therapies for children with autism and other... ...and purpose. The Lead Speech-Language Pathologist serves... ...with company, payer, and regulatory requirements. Educate families and caregivers on strategies that support progress outside...RegulatoryPermanent employmentTemporary work- Neurocrine Biosciences in San Diego is seeking a Regulatory Affairs professional to lead the review of medical education and promotional materials.... ...while assessing regulatory risks related to promotional strategies. The ideal candidate will have a strong background in...Regulatory
$220k - $245k
...strategic and experienced Director, Regulatory Affairs to lead global clinical regulatory... ...guidance, support product development strategy, and drive successful regulatory submissions... .... Experience supporting cell therapy, CAR‑T, or gene therapy programs is preferred, along...RegulatoryFull time- ...biotechnology consulting firm is seeking a Regulatory Affairs Consultant to support projects... ...requires expertise in regulatory strategy development, especially in relation to in... ...pharmaceutical products. Responsibilities include leading regulatory submissions, engaging with...RegulatoryRemote job10 hours per week
- ...diseases by silencing the genes that cause them. Using... ...delivery, Arrowhead therapies trigger the RNA... ...biologics. Arrowhead is leading the field in bringing... ...Management will lead the strategy, development, and deployment... ..., while ensuring regulatory compliance. This role...RegulatoryWork at office
- ...seeks a Senior Counsel to serve as the lead legal advisor for multiple business units... ...marketing, operations, compliance, and strategy. This fully remote role reports to the Assistant... ...and corporate transactions, IP, regulatory, M&A, and governance, partnering with external...RegulatoryRemote job
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