Executive Director, Regulatory Affairs
Confidential
Executive Director, Regulatory Affairs
About the Company
Esteemed company developing medicines for inflammatory & autoimmune diseases
Industry
Biotechnology
Type
Privately Held, VC-backed
Founded
2018
Employees
51-200
Funding
$101-$200 million
Categories
- Biotechnology
- Life Science
- Therapeutics
Specialties
- cell therapy
- autoimmune
- and lupus
- lupus
- multiple sclerosis
- systemic sclerosis
- scleroderma
- myasthenia gravis
- car t-cell
- and stiff-person syndrome
About the Role
The Company is seeking an Executive Director for Regulatory Affairs to provide strategic and operational leadership across its cell therapy portfolio. The successful candidate will be responsible for defining and executing global regulatory strategy to support the development, registration, and commercialization of advanced therapies, with a focus on commercial readiness, labeling strategy, and health authority engagement. This role requires a seasoned regulatory leader with deep experience in advanced therapies, capable of shaping regulatory strategy from early development through approval and launch, and partnering closely with cross-functional teams. The Executive Director will also be the primary interface with global health authorities, including the FDA, and will lead and support key regulatory meetings and negotiations. Applicants must have a Bachelor's degree in a scientific discipline (advanced degree preferred) and at least 15 years of progressive regulatory affairs experience in the pharmaceutical or biotechnology industry, with a significant background in advanced therapies. Experience in cell and/or gene therapy, particularly in the context of autoimmune diseases, is highly preferred. The role demands a proven track record in leading global regulatory strategies, including BLA/MAA experience, and a strong understanding of labeling strategy development and negotiation. Deep knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks is essential, with a preference for candidates with EMA and ex-US experience. The ideal candidate will have strong executive communication skills, the ability to influence senior leadership, and a strategic mindset that balances scientific rigor, regulatory compliance, and commercial impact.
Hiring Manager Title
SVP, Chief Regulatory Officer
Functions
- Legal
- Operations
- ...overseeing the operational execution of the company’s global Ethics... ...with legal requirements, regulatory expectations, and the company... ...Internal Communications.Government Affairs.Business and regional... ...Support reporting to the Board of Directors and appropriate Board...SuggestedTemporary workWork at officeImmediate startWorldwideFlexible hoursShift work
- ...responsible for overseeing the operational execution of the company's global Ethics &... ...and in alignment with legal requirements, regulatory expectations, and the company's values.The... ...Procurement.Internal Communications.Government Affairs.Business and regional leadership.Serve...Suggested
Western Digital
San Jose, CA2 hours ago - ...Compliance Officer to play a pivotal role in the operational execution of its global Ethics and Compliance program. The successful candidate... ..., consistently, and in alignment with legal requirements, regulatory expectations, and the company's values. This executive will be...Suggested
- ...serving as a cross-functional liaison, and working closely with the Director of Growth to drive the expansion of the expert community. The... ...setting direction and is equally adept at hands-on execution, and who can effectively engage with stakeholders across various...Suggested
$270.4k - $291.2k
...A global leader in life sciences is seeking a Director of Regulatory Affairs to provide strategic operational support, improve processes, and ensure compliance. The role requires 7-10 years of experience in Regulatory Affairs, strong project management skills, and expertise...SuggestedContract workRemote workBayside Solutions
Santa Clara, CA2 hours ago- ...strategic leader with a proven track record in communications, public affairs, and a deep understanding of how to influence and elevate an... ...advisor, with the ability to work closely with the CEO and executive team to elevate the organization's and the CEO's voice. The role...Local area
Confidential
San Jose, CA1 day ago $130 - $140 per hour
Director of Regulatory Affairs, Business Excellence 1 week ago Be among the first 25 applicants This range is provided by Bayside Solutions. Your... ...Affairs and their leadership team by strengthening execution, improving processes, and ensuring compliance across department...Contract workRemote work- ...and help our clients, communities, and each other.As part of our continued strategic growth, CLA is seeking a Principalor Signing Director to join our Bay Area Assurance team. This role is designed for a motivated leader who is excited to help build and grow our presence...Full time
$160k - $240k
...strategic professional focused on supporting key initiatives for the Office of the COO. CoS drives a tempo of disciplined and predictable execution and establishes operational priorities on behalf of the COO. Onto’s CoS is the behind-the-scenes leader guiding our operations...Permanent employmentFull timeWork at office$114k - $228k
...a best place to work for diversity, working mothers, female executives, and scientistsAbbott Vascular provides innovative, minimally... ...software, vessel closure devices and peripheral stents.This Regulatory Affairs Manager position is an onsite opportunity working out of our...Shift work$203k - $227k
...enhance the company’s global control environment and support management (First Line) in the identification of emerging risks. The Director, Global SOX Compliance Manager will be a trusted business partner helping to design and optimize business processes and controls,...WorldwideFlexible hours$165.18k - $247.5k
...Workplace Management. Led by the Senior Director of Enterprise Applications, the group works... ...management (CLM), e-billing, and regulatory compliance platforms.Ensure applications... ...Workplace.Facilitate steering committees, executive briefings, and governance reviews.Maintain...Permanent employmentContract workInternshipWork at officeWork from home$197k - $224k
...compliance and sustainability initiatives, ensuring adherence to regulatory standards.Shape the Future of Sustainability at Supermicro:... ...Impact High-Level Decision-Making: Your expertise will influence executive leadership and board decisions, driving sustainable business...Worldwide$246.8k - $355.2k
...st century. We are looking for a Senior Director, Compliance & Ethics to join our team in... ...advisor to leadership on legal and regulatory compliance, risk, and ethical business conduct... ...Ethics & Compliance ProgramDevelop, execute, and scale Bloom’s global compliance strategy...Full timeWork at officeWorldwide- ...team at Chester’s Corner Rescue Foundation. How You Will Contribute: Responsibilities: Support the President / Executive Director in organizational leadership and decision-making. Ensure continuity of operations and executive oversight in the President...Immediate start
Chester’s Corner Rescue Foundation
San Jose, CA1 day ago $171.9k - $289.9k
...Customer Success Managers, Sales, and Product teams to develop customized end-to-end enterprise solutions for your customers.Engage executive and technical stakeholders to present strategic roadmaps, ROI, and adoption strategies tied to consumption and usage goals.Drive...Full timeTemporary workLocal areaWorldwide- ...Vice President, Executive Search & Business Development About the Company Nationally recognized executive search firm Industry Staffing and Recruiting Type Privately Held Founded 1979 Employees 1-10 Categories Consulting & Professional Services...
- ...activities are effective and aligned across the organization. This executive will provide strategic direction to the compliance function,... ..., and oversee all aspects of compliance, including managing regulatory exams, audits, and reporting. The role also involves...
$195.2k - $260.6k
...communities to create economic opportunity for all.Payments Compliance Director - Governance & New Product AdvisoryLooking for a company that... ...compliance program across U.S. and international marketplace regulatory risks, while maintaining a strong governance framework for...Immediate startRemote workVisa sponsorship- About Centric Software:Centric Software is a global leader, providing an innovative and AI-enabled product-concept-to-commercialization platform for retailers, brands and manufacturers of all sizes. We equip retail, fashion, luxury, footwear, outdoor, home and consumer ...Full timeContract workRemote work
$160k - $200k
...International Trade Compliance (ITC) team, reporting to the Senior Director, International Trade Compliance or General Counsel. The Senior... ....Determine and implement new procedures as needed to address regulatory changes and emerging export compliance risks.Develop and...Work experience placementRemote workWork from homeFlexible hours- ...logistics for field employees, and manage compliance documentation. The role supports both remote and on-site staff while ensuring regulatory and organizational compliance. Join a venture-backed team focused on innovative recycling solutions, with opportunities for...Work at officeRemote work
Olyns
Santa Clara, CA2 hours ago $151k
...and risk in all that we do and achieve regulatory outcomes that support the business’ needs... ...Relationship This position reports to the Director, Electric Investigations Job... ...findings and risk to PG&E to senior and executive leaders. Stand up new compliance control...Work experience placementWork at officeRemote workFlexible hoursNight shiftPG&E Corporation
Milpitas, CA4 days ago- ...Work closely with on-site and corporate staff to ensure regulatory compliance with housing programs are met. Required to travel based on business need. Perform various audits and implement necessary solutions. Provide administrative support, includin Compliance Manager...
Apartment Management Consultants
San Jose, CA3 days ago - ...Job TitleResponsibilities:Regulatory submissions including Original ANDAs, Amendments, Annual Reports, Supplements and PADERs... ...Original submission/Amendments/ Supplements as assigned by the Director, Regulatory Affairs or VP, Regulatory Affairs.Participate in project calls...Contract workImmediate start
Katalyst HealthCares & Life Sciences
San Jose, CA2 days ago - ...play a pivotal role in this dynamic environment. The successful candidate will be a high-agency operator, adept at managing both executive-level priorities and day-to-day execution. This role is essential for driving complex, cross-functional work across various operational...
- ...role is focused on amplifying the CEO's and SLT's effectiveness, particularly in the areas of time management, decision-making, and execution. The successful candidate will be a trusted partner, gatekeeper, and execution lead, with a strong background in digital and e-...
$114k - $228k
...Abbott Regulatory Affairs ManagerAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio... ...a best place to work for diversity, working mothers, female executives, and scientistsAt Abbott, we believe people with diabetes...Abbott
Milpitas, CA2 days ago$161.93k - $269.88k
Position Summary This role supports the development and execution of strategic initiatives for the AI Assurance Market Offering... ...Governance & AssuranceDirectly align with enabling areas (e.g. PPN, Regulatory, Marketing & Comms, Sales Excellence) to ensure the AI...Full timeLocal areaVisa sponsorship- ...significant revenue trajectory, and the successful candidate will be instrumental in optimizing the time, focus, decision-making, and execution of the Senior Leadership Team. The Chief of Staff will be a trusted partner, gatekeeper, and execution lead, particularly in the...Remote work
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