Senior Vice President, Global Regulatory Affairs & Quality
$422kJobleads-US
Key Accountabilities / Core Job Responsibilities
- Establish and execute global regulatory affairs and quality strategies to support corporate objectives, product development, commercialization, and lifecycle management.
- Lead regulatory engagement and advocacy with global health authorities to advance approvals, maintain product licenses, and influence evolving regulatory frameworks.
- Direct enterprise quality systems and governance across GxP operations to ensure consistent compliance, product quality, and patient safety.
- Maintain organizational inspection readiness; oversee regulatory inspections, audits, compliance assessments, and remediation.
- Partner with Research, Development, Technical Operations, Manufacturing, Medical Affairs, Pharmacovigilance, Commercial, and Supply Chain to drive business performance and operational excellence.
- Oversee regulatory submissions, product registrations, labeling strategies, post-approval commitments, and lifecycle management activities across global markets.
- Establish enterprise risk management processes for regulatory, compliance, and quality risks.
- Drive continuous improvement, digital transformation, and data-driven quality initiatives.
- Develop and lead a high-performing global organization via workforce planning, succession management, leadership development, and talent acquisition.
- Advise executive leadership and the Board on regulatory strategy, quality performance, compliance risks, inspection outcomes, and industry trends.
Required Qualifications / Skills
- Bachelor’s degree in scientific, engineering, healthcare, or related discipline (advanced degree preferred).
- 20+ years progressive biotech/pharma/life sciences experience with significant executive leadership in Regulatory Affairs/Quality.
- Demonstrated success leading global regulatory strategy and quality organizations for development and commercial products across multiple regions.
- Extensive experience with major health authorities (e.g., FDA, EMA, PMDA, MHRA).
- Deep expertise in global regulatory frameworks, GxP, quality systems, inspection management, and enterprise compliance.
- Proven ability to lead large global organizations and influence enterprise strategy.
- Exceptional executive communication, stakeholder management, leadership, and decision-making.
Preferred
- Experience with global commercial product portfolios across multiple therapeutic areas.
- Experience leading enterprise digital quality, regulatory intelligence, or compliance transformation initiatives.
- Prior participation in executive leadership supporting public-company governance and Board interactions.
Benefits
- Salary range: $422,000.00 to $440,000.00.
- Denali offers a total rewards package including 401(k), healthcare coverage, and ESPP.
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior Vice President, Global Regulatory Affairs & Quality in South San Francisco, CA vacancy
$422k
...Key Accountabilities / Core Job Responsibilities Establish and execute global regulatory affairs and quality strategies to support corporate objectives, product development, commercialization, and lifecycle management. Lead regulatory engagement and advocacy with...QualitySeniorScorpion Therapeutics
South San Francisco, CA2 days ago$300k - $420k
...therapeutic platform. They are seeking a Senior Vice President of Regulatory Affairs to oversee all regulatory... ...their primary strategic advisor on global regulatory strategy. You will proactively... ...goals; ensure on-time, high-quality, regulatory-compliant submissions....QualitySeniorLocal areaRelocationFlexible hours3 days per weekDennis Partners
San Francisco, CA4 hours ago- ...Scorpion Therapeutics, located in South San Francisco, CA, is seeking an experienced executive to lead global regulatory affairs and quality strategies. The role involves establishing compliance frameworks, overseeing regulatory submissions, and engaging with health authorities...Quality
$240k - $300k
Structure Therapeutics Inc. is seeking a Senior Director of GMP Quality Assurance in South San Francisco. This role leads the global GMP QA strategy, ensuring compliance and quality system design as the company advances from clinical to commercial stages. Qualified candidates...QualitySenior$160k - $240k
The Senior Vice President will lead client relationships, teams, and projects for capital markets... ...relevant Edelman teams to deliver high‑quality, integrated service. Act as the primary... ...to detail. Collaborate with global Edelman Smithfield teams to grow and develop...QualitySeniorWork experience placementLocal area- ...Position Summary Senior Director, Regulatory Operations provides strategic and operational leadership for global regulatory operations, overseeing electronic submissions... .... Partners with Regulatory Affairs leadership, IT, Quality, and cross-functional teams to ensure...QualitySeniorWorldwide
Scorpion Therapeutics
South San Francisco, CA5 days ago $240k - $300k
...innovators and financed by top‑tier global life sciences investors. The company... ...Position Summary We are seeking a Senior Director of GMP Quality Assurance (QA) to serve as a senior... ...alignment with global quality standards and regulatory expectations. This role partners...QualitySeniorContract work$140k - $214k
...Vera Therapeutics retains all global developmental and... ...Summary Vera is seeking a Senior Manager, Regulatory CMC to join an experienced,... ...development to create high quality regulatory submissions that... ...requirements. Represent Regulatory Affairs on cross‑functional project...QualitySenior- ...ground floor and shape both the regulatory function and broader... ...looking for a Head of Regulatory Affairs (VP/SVP) who can build the regulatory... .... Key Responsibilities Own global regulatory strategy across... ...and maintain a culture of quality from day one What We're Looking...Quality
$300k - $390k
...financed by top‑tier global life sciences investors... ...launch, we are seeking a Vice President, Global Manufacturing... ...and results‑oriented senior leader within... ...performance, including quality, timelines, cost, and... ...Partner with Quality and Regulatory to ensure GMP compliance...QualityInterim role$235k - $285k
...experienced and highly motivated Director/Senior Director of Regulatory Affairs to lead regulatory strategy and... ...submissions, and interactions with global health authorities. The ideal candidate... ..., review, and submission of high‑quality regulatory documents, including INDs...QualitySeniorFull time$263.88k - $307.86k
## Senior Director, Regulatory Affairs REMS ProgramApplylocations: South San Francisco, Californiatime type:... ...practices# REMS Design & Governance* Own global oversight of REMS design, including... ...regulatory perspective.* Align with Quality to ensure inspection readiness,...QualitySeniorFor contractors$89.2k - $169.5k
Boston Scientific is hiring for a Senior Supervisor to lead the Global Quality Distribution Product Controls team. In this hybrid role, you'll oversee operations, ensure compliance, and develop team capacities. Qualified candidates will hold a Bachelor’s degree and possess...QualitySenior- Dormont Manufacturing Co is looking for an International Tax Senior Manager to enhance its growing International Tax practice. This role... ...international tax challenges and lead a team in delivering quality tax planning. The ideal candidate will have over 8 years of experience...QualitySenior
- Structure Therapeutics in South San Francisco is seeking a Senior Director of GMP Quality Assurance to lead the global GMP QA strategy, ensuring compliance and overseeing quality operations. The successful candidate will have over 15 years of experience in quality management...Quality
- Zip is seeking a Senior Manager for Global Workplace Operations in San Francisco. This role involves owning the operational engine of Zip's workplace... ...and enforce standards across locations, ensuring a high-quality employee experience while navigating the complexities of...QualitySeniorWork at office
$235k - $280k
...Undertake client care surveys to monitor performance. Serve as senior-level technical knowledge resource regarding project management,... ..., procedures, templates and products. RELATED OCCUPATION: Global Program Controls Lead or any other job title performing the...SeniorFull timeWork at officeLocal areaFlexible hoursTurner & Townsend
San Francisco, CA6 days ago$90.5k - $154.43k
...International is seeking a Transfer Pricing Senior Associate in San Jose, CA. This role offers the chance to collaborate globally, providing transfer pricing advisory to multinational... ...in functional analysis, and contribute to quality consulting projects. Ideal candidates have a...QualitySeniorRemote job$94k - $174.6k
Position Overview Senior Quality Compliance Specialist - responsible for designing and implementing... ...initiatives, ensuring compliance with global regulations and Roche internal... ...operations preferred; extensive experience with regulatory inspections and health authority...QualitySeniorLocal areaRelocation package$220.6k - $275.7k
...Position Summary The Senior Director, Regulatory Operations provides strategic... ...operational leadership for global regulatory operations,... ...member of the Global Regulatory Affairs Leadership Team and plays a... ...Affairs leadership, IT, Quality, and crossfunctional teams...QualitySeniorWork at officeLocal areaRemote workWorldwideNight shift3 days per weekACADIA Pharmaceuticals
South San Francisco, CA2 days ago$163.6k - $245.4k
...Client, Banking, Markets, and Technology. We are looking for a Senior Vice President who is highly motivated to (a) develop investment theses, (b... ..., internal approvals; lead follow-ons. Maintain high quality analysis, including supervision of junior output. Support negotiation...QualitySeniorFull time$200k - $250k
...At Ascensus we are guided by our Core Values of People Matter, Quality First and Integrity Always®. They inspire us every day to prioritize... ...to support this new solution As required, partner with senior leaders to execute on the organizational design P&L Define product...QualitySeniorWork at officeRemote work$173.39k - $210.11k
...reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan... ...Requirements Detail-oriented with commitment to quality Basic knowledge of disease area,... ...bereavement, and military needs and an annual Global Shutdown between Christmas and New Years...QualitySeniorHourly payFull timeTemporary workSummer workFlexible hoursShift work$336k - $405k
...Vice President, Clinical Development Reporting... ...development and regulatory objectives. The... ...Development serves as a senior leader within... ..., Regulatory Affairs, Medical Affairs,... .... Ensure high-quality execution of clinical... ...with global Health Authorities...QualityRigel Pharmaceuticals
South San Francisco, CA1 day ago- A global financial platform company in San Francisco is seeking a skilled Frontend Engineer to enhance their web interfaces for procurement... ...with product managers and designers to deliver high-quality user experiences. Join a team that values innovation and technical...QualitySenior
$360k - $425k
...About the role: The Vice President, Clinical Development... ...Clinical Operations, Regulatory Affairs, Translational Science, Safety, Quality and others in supporting... ...development at senior executive meetings... ...is highly desirable Global experience in clinical...QualityInternshipWork at officeLocal areaRemote workAllogene Therapeutics
South San Francisco, CA5 days ago$265k - $331k
...Executive Director (ED) of Global Patient Safety (GPS) Quality and Compliance to join our... ...to ensure compliance with regulatory requirements to safeguard... ...Data Science, Regulatory Affairs, Quality Assurance, Medical... ...Provide regular updates to senior leadership on the status...QualityFull timeContract workLocal area$225k - $275k
The Blackstone Group L.P. is seeking a Senior Vice President Attorney for the Private Wealth Public Funds Legal Group in San Francisco. This role involves overseeing legal matters for BREIT, including preparing public offering materials, managing corporate governance, and...SeniorFull time- Dimerco Express Corp is seeking motivated individuals to enhance global shipping and logistics efficiency. Join a supportive... ...needs, participating in compliance projects, and improving service quality across Business Units in the US and beyond. Dimerco offers various...Quality
$240k - $275k
The International Executive Service Corps is hiring a Director of Clinical Regulatory Affairs to shape and execute the global clinical regulatory strategy. The role involves overseeing clinical submissions and ensuring compliance with regulatory requirements. The ideal...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Vice President, Global Regulatory Affairs & Quality. Be the first to apply!
Related searches
- vp biotech South San Francisco, CA
- vp compliance South San Francisco, CA
- vice president global communications South San Francisco, CA
- vice president of ecommerce South San Francisco, CA
- vice president real estate development South San Francisco, CA
- vp safety South San Francisco, CA
- vp customer experience South San Francisco, CA
- vice president risk management South San Francisco, CA
- vice president design South San Francisco, CA
- vice president of construction South San Francisco, CA