Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Regulatory Strategy Lead for Drug Development

Neurocrine Biosciences

Neurocrine Biosciences in San Diego seeks a Regulatory Affairs professional to drive regulatory strategy execution for development programs. You will collaborate with the Director of Regulatory Affairs to prepare submissions (IND/CTA, NDA/BLA), maintain processes, and represent regulatory perspectives on cross‑functional teams. The role leads regulatory filings, guides global strategies for CMC, nonclinical and clinical activities, and ensures compliance with FDA and ICH guidelines. #J-18808-Ljbffr Neurocrine Biosciences

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Regulatory Strategy Lead for Drug Development in San Diego, CA vacancy
  • $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

    Neurocrine Biosciences

    San Diego, CA
    2 days ago
  • 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... 
    Regulatory
    Remote job

    Role, Inc.

    San Diego, CA
    4 days ago
  •  ...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

    Iambic

    San Diego, CA
    4 days ago
  •  ...developing innovative drugs for diseases with a genetic...  .... Arrowhead is leading the field in bringing...  ...CA with research and development teams in Madison, WI &...  ...comprehensive quality assurance strategy aligned with...  ...compliance/alignment with regulatory requirements and internal... 
    Regulatory

    Arrowhead Pharmaceuticals, Inc.

    San Diego, CA
    2 days ago
  • 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... 
    Regulatory
    Remote job

    Role, Inc.

    San Diego, CA
    4 days ago
  •  ...Global Commercial Product Strategy The Director, Global...  ...lifecycle, from early development through launch and lifecycle optimization. Leads the cross functional...  ...pipeline, clinical data, regulatory milestones, and...  ...learnings to strategy and drug development. Commercialization... 
    Regulatory
    Temporary work
    Work at office
    Local area
    Remote work
    Night shift

    Acadia Pharmaceuticals

    San Diego, CA
    5 days ago
  •  ...biotechnology consulting firm is seeking a Regulatory Affairs Consultant to support projects...  ...requires expertise in regulatory strategy development, especially in relation to in-silico modeling...  ...products. Responsibilities include leading regulatory submissions, engaging with... 
    Regulatory
    Remote job
    10 hours per week

    Pharmatech Associates

    San Diego, CA
    4 days ago
  •  ...This senior role involves designing data-driven strategies and being the statistical authority for drug product development programs. Collaborating with various...  ...across functions, influencing teams, and ensuring regulatory compliance. #J-18808-Ljbffr Neurocrine Biosciences
    Regulatory

    Neurocrine Biosciences

    San Diego, CA
    2 days ago
  • $120.97k

     ...leadership, career growth and development for every employee. We...  ...remedial action strategies, ensuring the...  ...Design-Build Experience: Lead or support the design-...  ...adheres to firm policies, regulatory requirements (CERCLA,...  ...Background Check and Drug Testing Information... 
    Regulatory
    H1b

    CDM Smith

    San Diego, CA
    2 days ago
  • $181.83k - $272.8k

     ...governance and clinical product strategy across case management and...  ...Translate client, purchaser, and regulatory requirements into actionable...  ...supports new business growth Lead design and scaling of clinical...  ...must pass a background check/drug screen. Qualified applicants with... 
    Regulatory
    Full time
    Part time
    Work at office
    Local area
    Work from home
    Home office
    2 days per week

    Blue Shield of California

    San Diego, CA
    4 days ago
  •  ...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... 
    Regulatory

    EPM Scientific

    San Diego, CA
    4 days ago
  • $239.4k - $299.2k

     ...Global Commercial Product Strategy is responsible for...  ...lifecycle, from early development through launch and lifecycle optimization. Leads the cross functional Global...  ..., clinical data, regulatory milestones, and launches...  ...learnings to strategy and drug development. Commercialization... 
    Regulatory
    Work at office
    Local area
    3 days per week

    Acadia Pharmaceuticals

    San Diego, CA
    2 days ago
  • $165k - $205k

     ...an Associate Director of Microbiology to lead the microbiology function for revolutionary...  ...proven background in team building and assay development. The ideal candidate will spearhead the microbiology strategy, ensuring regulatory compliance and quality standards across... 
    Regulatory

    Sarmal

    San Diego, CA
    4 days ago
  • $190k - $240k

     ...transportation, water resources, land development, government, and federal...  ...& Structures team, you will lead the development and delivery...  ...coordination. Regional Strategy & Execution Contribute...  ...navigating complex technical, regulatory, and stakeholder challenges.... 
    Regulatory
    Contract work
    Work at office
    Local area
    Flexible hours

    BKF

    San Diego, CA
    4 days ago
  • Travere Therapeutics in San Diego is seeking a Manager of Regulatory Affairs to provide regulatory leadership and support for late-stage development programs. The role requires expertise in regulatory strategies, submission execution, and interactions with health authorities... 
    Regulatory

    Travere Therapeutics

    San Diego, CA
    5 days ago
  • ALKU is seeking a senior Regulatory Affairs leader to oversee regulatory...  ...across the organization’s development portfolio. You will provide...  ...California, you will shape strategies, oversee IND/CTA and NDA/BLA...  ...authorities, and lead cross‑functional teams to ensure... 
    Regulatory

    ALKU

    San Diego, CA
    2 days ago
  •  ...spearheading the design and business strategy for cutting-edge biotech...  ...that enable innovation in drug development, biologics, and advanced...  ...Monitor industry trends and regulatory changes to ensure compliance...  ...-class biotech facilities. Lead design proposals for new labs... 
    Regulatory

    Harley Ellis Devereaux (HED)

    Chula Vista, CA
    1 day ago
  • 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...  ...senior leadership decisions to optimize development timelines and enhance commercial value.... 
    Regulatory

    Neurocrine Biosciences

    San Diego, CA
    4 days ago
  •  ...change. Within SRCO, the SOX Strategy, Operations & Audit Excellence...  ...Summary We're looking for a Lead, SOX Program Strategy & Audit...  ...assessment, management action plan development, and remediation monitoring...  ...team. Monitor the evolving regulatory environment (PCAOB, SEC) and... 
    Regulatory
    Work experience placement
    Work at office

    Intuit

    San Diego, CA
    5 days ago
  •  ...is seeking a Senior Director/Director of AOC Analytical Development & Quality Control. This role will lead analytical strategy and quality control activities, manage teams, and ensure compliance with regulatory requirements. Ideal candidates should possess a strong background... 
    Regulatory

    Atrium Therapeutics

    San Diego, CA
    4 days ago
  • Arrowhead Pharmaceuticals is seeking a Director of Regulatory Affairs who will lead the labeling strategy for global product development. This position entails managing labeling documents throughout all phases of development and post-approval, ensuring compliance with the... 
    Regulatory

    Arrowhead Pharmaceuticals

    San Diego, CA
    4 days ago
  • $110.8k - $151k

     ...Biosciences is seeking a Senior Scientist for Analytical Development to manage analytical activities for drug substances from preclinical to commercial phase....  ...procedures, and ensuring compliance with regulatory standards. Ideal candidates will possess a relevant... 
    Regulatory

    Neurocrine Biosciences

    San Diego, CA
    4 days ago
  • Blue Shield of CA is seeking a Product Strategist, Consultant in the Product Strategy team for the Small Business market. You will translate market insights and regulatory requirements into actionable product strategies, roadmaps, and business cases to guide portfolio... 
    Regulatory
    Work at office
    2 days per week

    Blue Shield of CA

    San Diego, CA
    4 days ago
  •  ...diagnostic products. You will identify market opportunities, support launches, and shape lifecycle strategies by translating customer insights into actionable plans across R&D, regulatory, commercial, and operations. Collaborate across cross‑functional teams, monitor market... 
    Regulatory

    Hologic, Inc.

    San Diego, CA
    4 days ago
  • $200k - $265k

     ...Director/Director, Medical Affairs Strategy About Soleno Therapeutics Inc...  ...company focused on the development and commercialization of novel...  ...inform medical strategies. Lead and participate in advisory boards...  .... In‑depth knowledge of the regulatory environment and compliance... 
    Regulatory

    Soleno Therapeutics, Inc.

    San Diego, CA
    1 day ago
  •  ...Executive Medical Director, Drug Safety About the Company Highly regarded biopharmaceutical...  ...of safety surveillance processes, the development of risk management plans, and the...  ...the pharmaceutical, biotech, CRO, or regulatory agency. The role requires a strong... 
    Regulatory

    Confidential

    San Diego, CA
    2 days ago
  • $181k - $226k

     ...portfolio leadership, new product development, and the identification of...  ...role that blends product strategy, technology scouting, opportunity...  ...development, finance, regulatory, and commercial teams globally...  ...feasibility, and competitive impact. Lead structured assessments of... 
    Regulatory
    Temporary work
    Work experience placement
    Flexible hours
    3 days per week

    SwiftCruit

    San Diego, CA
    2 days ago
  •  ...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

    Beta Bionics, Inc.

    San Diego, CA
    2 days ago
  •  ...Vice President of Preclinical Drug Development Kelly Science & Clinical...  ...with one of our clients, a leading non-profit translational research...  ...Development to drive strategy and execution across the full...  ...chemistry, biology, DMPK, CMC, regulatory, and clinical teams.... 
    Regulatory
    Full time
    Temporary work
    Flexible hours

    Kelly

    San Diego, CA
    20 hours ago
  • $181k - $226k

     ...the Role We’re looking for a Lead Product Manager - Digital & AI to drive the vision, strategy, and execution of new digital...  ...experimentation. Lead 0→1 product development from concept and prototype...  ...engineering, AI/ML, clinical, regulatory, and commercial teams to deliver... 
    Regulatory
    Temporary work
    Remote work
    Flexible hours

    Resmed

    San Diego, CA
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Regulatory Strategy Lead for Drug Development. Be the first to apply!