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 5 days ago
Similar jobs that could be interesting for youBased on the Director of Regulatory Strategy & Submissions in Fremont, CA vacancy
- Taiho Oncology, Inc. seeks a senior Director to lead global regulatory CMC activities, coordinating strategy, submissions, and approvals across US, EU, and other regions. This role partners with internal teams and external consultants to ensure compliant development and...Suggested
- Noctrix Health, Inc. is seeking a strategic Director of Clinical Affairs to lead planning, execution, and oversight of clinical... ...wearable therapy. You will drive evidence generation to support regulatory submissions, reimbursement, and commercialization while ensuring...Suggested
- 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
$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- Enovix Corporation in Fremont, California seeks a seasoned Product Manager to own drone product lines from concept to execution. You will collaborate with design, R&D, manufacturing, procurement, sales and finance to align cross-functional teams and deliver high quality...Suggested
$195k - $235k
...Director, Strategic Sourcing About Us Protagonist Therapeutics is a biopharmaceutical... ...for further clinical and regulatory development and commercialization. Protagonist... ...budget constraints and align sourcing strategies and timelines. Analyze spend data...Full timeContract workTemporary workWork at officeWorldwideFlexible hoursProtagonist Therapeutics
Newark, CA4 days ago- AMAX in Fremont, CA is seeking a program manager to own customer projects, lead the focus team, plan schedules, monitor execution, and coordinate with internal teams to ensure manufacturing outcomes and customer satisfaction. You will manage the full program lifecycle, ...
- Astreya in Fremont, CA seeks a Project & Program Management II to coordinate multiple cross‑functional technical programs from initiation to completion. You will organize plan, manage risks, and report progress to executives, while aligning with business goals and timelines...
- ...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...Flexible hours
- ...and multilingual candidates are encouraged to apply. Program Director – Care Operations & Patient Services Position Overview The Program... ...-party billing vendor to manage insurance contracts, claim submissions, authorizations, rate changes, and escalations. Quality & Accreditation...Full timeRemote work
HERS Breast Cancer Foundation
Fremont, CA4 days ago $140k - $205.37k
...key component related ECRs Develop and implement supply chain strategies for key components used in electrical control units, ensuring... ...requests and is not monitored for job applications or resume submissions. To be considered for employment, all applications must be...Hourly pay- 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...
$155k - $324k
...innovation for a better world together, anything is possible. Director, Spares Planning Date: Aug 18, 2026 Location: Fremont, CA, US... ...Parts Planning functions. This role develops and executes strategies that support the mission and vision of Global Spares Planning,...Local areaRemote workFlexible hours2 days per week3 days per week1 day per week- Protagonist Therapeutics seeks a Director of Strategic Sourcing to drive cost savings, optimize supplier relationships, and ensure operational efficiency across CROs, IT, travel, contract renewals, and manufacturing. You will negotiate discounts and identify opportunities...Contract workWork at office
$140k - $149k
Director, Custodial Equipment Strategy# **Job Description:****NOW HIRING: Director of Custodial Equipment Strategy****Compensation: $140,000-$149,000 per year**SBM is looking for a Director to develop and scale a holistic equipment strategy for our organization. As a global...Work at officeImmediate start- Office Administrator Job Description We are a small, growing wedding photography and videography company looking for a responsible and organized Planning Manager to help manage our day-to-day wedding planning and scheduling operations. Responsibilities: Manage wedding bookings...Work at office
$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- Lam Research seeks a Director of Service Parts Planning to lead global parts planning, aligning regional and global teams to deliver differentiated... ...you will partner with Operations, Supply Chain, Finance, and regional teams, guiding strategy deployment, #J-18808-Ljbffr Lam Research
- Pivotal Systems is seeking a Director of Environmental, Health & Safety to lead the EH&S function across engineering, manufacturing, and R&D operations. This role sets safety vision, manages regulatory compliance, and oversees gas lab operations for semiconductor equipment...
- Bionova Scientific LLC in Fremont, CA, is seeking a Sr. Director of Quality Control to lead the QC function within a fast-growing biologics CDMO. This hybrid, full-time role guides analytical strategy, sample management, in-process and environmental monitoring, release...Full time
- Sulekha.com New Media Pvt Ltd is seeking an Office Administrator to manage wedding bookings, client information, and scheduling for a small wedding photography/videography team. You will maintain CRM data, coordinate calendars and timelines, and communicate with couples...Work at office
- Lam Research is seeking a Technical Program Manager 5 in Fremont, CA to lead cross-functional teams from initiation through delivery of advanced semiconductor equipment programs. You will blend technical acumen with strategic planning to drive new or upgraded products in...
- Lam Research seeks a seasoned Program/Project Manager to lead complex, cross-functional initiatives from initiation to delivery in the San Francisco Bay Area. You will coordinate engineering, operations, supply chain, and quality teams to meet scope, schedule, and budget...
$191k - $202k
...inspection readiness activities and host internal, vendor, and regulatory agency inspections (FDA, EMA, Health Canada).Lead Quality... ...functionally and contribute quality expertise to all regulatory submissions (IND, CTA) through authoring, review, and approval of...Aspect Biosystems
Fremont, CA4 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...- ...strengthen planning accuracy, execution discipline, and operational performancePresenting supply plans, risks, trade-offs, and allocation strategies to business leadership on a regular basisRequired qualifications include:Bachelor's degree in Engineering, Supply Chain,...Contract workShift work
The Hiring Method LLC
Fremont, CA1 day ago - ...Scientific LLC in Fremont, CA is seeking a Sr. Director of Quality Control to lead the QC... ...develop robust analytical transfer strategies with clients and our Analytical Development... ...analytics, cGMP compliance, and global regulatory collaboration, with a strong emphasis...
$200k - $230k
Alamar Biosciences in Fremont, California is looking for a Director of Product Management for Assays/Consumables. The ideal candidate will lead the product management of assay and reagent products, drive strategic initiatives, and manage product launches while ensuring...- Cytek Biosciences is seeking a Sr. Director, Clinical Platforms to lead the clinical platforms product marketing strategy worldwide for flow cytometry instruments, reagents,... ...services. You will align with R&D, Quality, Regulatory, Operations, PMO and Sales to drive...Worldwide
- Glutopia is seeking a Medical Director to provide clinical guidance and strategic insights within their Diabetes care platform. This role... ...the company to clinicians and driving the clinical strategy to retain and grow the clinical user network. The ideal candidate...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director of Regulatory Strategy & Submissions. Be the first to apply!
Related searches
- compliance manager Fremont, CA
- manager regulatory affairs Fremont, CA
- regulatory manager Fremont, CA
- head compliance Fremont, CA
- regulatory affairs director Fremont, CA
- regulatory & compliance manager Fremont, CA
- compliance director Fremont, CA
- sales excellence & strategy manager Fremont, CA
- strategic planning director Fremont, CA
- strategic director Fremont, CA