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

Director of Regulatory Strategy & Submissions

Nova Pneuma, Inc.

Nova Pneuma, Inc. is a clinical-stage biotechnology company seeking a senior regulatory affairs leader to manage all regulatory activities and counsel R&D and commercial teams. You will translate regulatory requirements into practical plans and coordinate with partners for submissions. This role requires IND and NDA experience, CDER/CDRH knowledge, and a proven track record leading submissions from pre-IND to approval. #J-18808-Ljbffr Nova Pneuma, Inc.

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Director of Regulatory Strategy & Submissions in Fremont, CA vacancy
  • $230k

    Nova Pneuma, Inc. in Fremont, CA seeks a Regulatory Manager to oversee regulatory strategies and submissions for product candidates. The ideal candidate will manage regulatory compliance from pre-IND through approval while liaising with project teams and regulatory authorities... 
    Suggested

    Nova Pneuma, Inc. a wholly owned subsidiary of Lee's Pharmac...

    Fremont, CA
    1 day ago
  •  ...A leading medical device company in California is seeking an experienced professional to lead Quality Assurance and Regulatory Affairs teams. This role requires 15+ years of experience in medical device quality assurance and strong leadership skills. The successful candidate... 
    Suggested

    Moximed

    Fremont, CA
    4 days ago
  • $230k

     ...conditions are treated. Job Summary Manage all regulatory activities for the company. Work with partners...  ...Responsibilities Develop and implement regulatory strategies for programs that will lead to the successful submission of product candidates from pre-IND stage... 
    Suggested

    Nova Pneuma, Inc.

    Fremont, CA
    19 hours ago
  •  ...cGMP operations, ensuring readiness for audits and long‑term regulatory compliance. Essential Duties And Responsibilities Quality System...  ..., and verification and validation planning. Support 510(k) submission readiness activities, including Technical File compilation, design... 
    Suggested
    Shift work

    Cytek Biosciences

    Fremont, CA
    3 days ago
  •  ...internal staff and scientific consultants who contribute to regulatory submissions, ensuring that appropriate information complies with...  ...publications for impact on current and future development strategies. Regulatory Affairs: Lead and develop a Regulatory Affairs... 
    Suggested
    Flexible hours

    Moximed

    Fremont, CA
    4 days ago
  • We are hiring now for a Planning Manager! SMTC Corporation was founded in 1985. SMTC is a mid-size provider of end-to-end electronics manufacturing services (EMS) including PCBA production, systems integration and comprehensive testing services, enclosure fabrication...
    Temporary work
    Work at office

    Prescient Edge

    Fremont, CA
    2 days ago
  • $117k - $143k

     ...and in the lives of patients we serve. Position Summary: The Regulatory Systems Manager is responsible for the administration,...  ...accurately and efficiently across systems that support regulatory submissions, health authority interactions, and product lifecycle management... 
    Full time
    Flexible hours

    Ardelyx

    Newark, CA
    3 days ago
  • $100k - $125k

    Business Planning Manager The Business Planning Manager combines forward-looking business planning (validating assumptions, tracking performance, and driving cost optimization and process improvements) with strong financial governance (internal controls, compliance,...
    Work at office
    Local area

    ASUS

    Fremont, CA
    1 day ago
  • ASUS is seeking a Business Planning Manager in Fremont, CA to lead financial governance and forward-looking planning for the regional branch. You will validate assumptions, track performance, and drive cost optimization while ensuring compliance with corporate standards...

    ASUSTeK Computer Inc.

    Fremont, CA
    2 days ago
  • $5,000 per month

     ...Clinical Manager reports to the Director of Programs. This...  ...coach staff in best practice strategies.Ensure quality of services and...  ...records including timely submission of all utilization, fidelity...  ...policies and protocols and all regulatory requirements.Work with... 
    Full time
    Casual work
    Work at office
    Local area
    Trial period
    Visa sponsorship
    Work visa
    Relocation package
    Flexible hours
    Afternoon shift
    2 days per week
    3 days per week

    First Place

    Union City, CA
    1 day ago
  • A technology company based in Fremont, California, is seeking an experienced Product Manager to drive revenue and market share. The candidate will be responsible for managing product development and building strong relationships with customers. With over 10 years of experience...

    Coherent Corp.

    Fremont, CA
    2 days ago
  • $191k - $202k

     ...inspection readiness activities and host internal, vendor, and regulatory agency inspections (FDA, EMA, Health Canada). Lead Quality...  ...and contribute quality expertise to all regulatory submissions (IND, CTA) through authoring, review, and approval of relevant... 
    Local area

    Aspect Biosystems

    Fremont, CA
    2 days ago
  • $34.74 per hour

     ...meetings, and other public‑facing activities. Prepare reports, presentations, correspondence, and other materials; ensure the timely submission of required information and documentation. Supervise, train, and provide direction to student workers and volunteers as assigned... 
    Hourly pay
    Temporary work
    Work at office
    Night shift
    Weekend work

    Ohlone College

    Fremont, CA
    4 days ago
  •  ...for driving market share and profitability objectives. Typical duties include working with various stakeholders, executing product strategies, and collaborating with marketing and sales teams. Experience in semiconductor equipment is preferred. Lam offers flexible work... 
    Remote work
    Flexible hours

    Lam Research

    Fremont, CA
    2 days ago
  • $225k - $250k

    Senior Director, Corporate Strategy Join to apply for the Senior Director, Corporate Strategy role at Fiery Fiery LLC is a leading provider of Digital Front Ends (DFEs) and workflow solutions for the printing industry. Fiery is leading the transformation from analog to... 
    Full time

    Fiery

    Fremont, CA
    22 hours ago
  • A technology solutions provider located in Fremont, California, is seeking a Director of Communication Intelligence. This senior role involves leading strategies and managing the COMINT division, focusing on sales and product management to drive growth. The ideal candidate... 

    Flash Technology, LLC

    Fremont, CA
    3 days ago
  • $175k - $195k

     ...Nashville, TN Role Overview The Sr. Manager, Strategic Sourcing (Fasteners & Tools) leads the development and execution of sourcing strategies, policies, and operational plans for mechanical categories across Nextpower. This role is responsible for driving cost, quality,... 

    Nextpower

    Fremont, CA
    2 days ago
  • $114k - $253k

    The group you’ll be a part of The Corporate Strategy Group charts our course for long-term profitable growth. This team drives Lam in the development of and alignment to our strategic priorities and key initiatives. Additionally, they oversee Lam's Corporate Development... 
    Local area
    Remote work
    Flexible hours
    2 days per week
    3 days per week
    1 day per week

    Lam Research

    Fremont, CA
    2 days ago
  • $130k - $160k

    A leading technology firm in Fremont, CA is seeking a Key Account Program Manager with expertise in display systems. The ideal candidate will lead multi-disciplinary project teams and manage key customer accounts, ensuring successful product development and customer satisfaction...

    E Ink Corporation

    Fremont, CA
    2 days ago
  • TD SYNNEX in Fremont, CA is seeking a Supply Chain Program Management professional to oversee new projects for US-based customers. The role acts as the primary interface with customers, coordinating demand-supply status and liaising with cross-regional planners for material...

    TD SYNNEX

    Fremont, CA
    2 days ago
  • Quanta Manufacturing Fremont is looking for an EHS Manager to oversee the organization’s Environmental, Health, and Safety (EHS) programs and ensure compliance with regulations. The role includes developing and improving policies, managing training, and leading initiatives...

    Quanta Manufacturing Fremont

    Fremont, CA
    2 days ago
  • $159k

     ...Job Category: Business Operations / Strategy  Job Level: Senior Manager Business...  ...enterprise policies and external/internal regulatory requirements. It partners cross-functionally...  ...or supervision of a manager or director Ability to analyze complex problems and... 
    Contract work
    Work experience placement
    Work at office
    Flexible hours
    2 days per week
    3 days per week

    PG&E Corporation

    Fremont, CA
    1 day ago
  •  ...excellent customer service skills and experience in research regulatory compliance, specifically with review boards: institutional review...  ...practices with respect to pre-award grant preparation and submission; post-award tracking and reporting; protocol creation and processing... 
    Work at office
    Remote work
    Flexible hours
    Night shift

    Key Solutions

    Fremont, CA
    5 days ago
  •  ...development, and continuous improvement. The position reports to the Chief Supply Chain Officer. Primary Responsibilities Lead supply chain strategy and execution for NPI programs, customer onboarding, and production ramp activities Develop and implement sourcing strategies that... 
    Work at office

    Unigen

    Newark, CA
    20 hours ago
  • $140k - $150k

    Job Type Full-time Description About Us G&H is a world leader in optical designing, testing and manufacturing. As experts in the technology of light, G&H works with customers to provide optical systems, assemblies, and components for demanding applications...
    Full time

    Gooch & Housego PLC

    Fremont, CA
    5 days ago
  • The Alameda County Office of Education is seeking a Director III for District Business Services to provide strategic leadership and oversight in fiscal management and compliance. This full-time role includes guiding departmental staff, supporting school districts, and... 
    Full time
    Work at office
    Local area

    Alameda County Office of Education

    Hayward, CA
    2 days ago
  • $180k - $240k

    Corsair is seeking an experienced tax professional to manage foreign corporate income tax returns and analyze international income tax provisions. The ideal candidate will have over 8 years of experience in public accounting or a multinational corporate environment, along...

    Corsair

    Milpitas, CA
    2 days ago
  • Description About Us G&H is a world leader in optical designing, testing and manufacturing. As experts in the technology of light, G&H works with customers to provide optical systems, assemblies, and components for demanding applications. Headquartered in Ilminster Somerset...

    Gooch & Housego Pal Alto

    Fremont, CA
    4 days ago
  • $170k - $185k

     ...identity, sexual orientation, or disability. Posted positions are not open to third‑party recruiters/agencies and unsolicited résumé submissions will be considered free referrals. If you are an individual with a disability and require reasonable accommodation to complete... 
    Full time
    Temporary work
    Summer holiday
    Worldwide
    Flexible hours

    SupportFinity

    Fremont, CA
    2 days ago
  • $108k - $162k

     ...new vehicle deployments and inventory management, balancing supply with regional demand while maintaining compliance with import, regulatory, and safety requirements Define, track, and improve key operational metrics (e.g., order matching accuracy, dwell time,... 
    Hourly pay
    Full time
    Temporary work
    Work at office
    Flexible hours

    Tesla Motors, Inc.

    Fremont, CA
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Director of Regulatory Strategy & Submissions. Be the first to apply!