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
- ...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...SuggestedLocal area
Confidential
San Jose, CA1 day ago - ...The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission strategy, identifying...SuggestedHourly payFull timeTemporary work
$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...SuggestedRemote jobContract work- Insider, Inc. is looking for a Program Manager to lead complex technical projects across various disciplines in San Jose, California. As a Program Manager, you will drive best practices and establish a company-wide PMO while mentoring a team of high-performing program ...Suggested
INSIDER
San Jose, CA2 days ago - ...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...SuggestedImmediate start
Chester’s Corner Rescue Foundation
San Jose, CA18 hours ago $160k - $240k
...professional focused on supporting key initiatives for the Office of the COO. The 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 officeOnto Innovation
Milpitas, CA18 days ago$207.5k - $281k
...our customers all over the world! We are seeking a Principal Regulatory Compliance Manager to serve as a senior technical authority supporting... .... Lead and significantly contribute to the design and execution of compliance monitoring, testing, and control challenge...Local area3 days per weekIntuit
Mountain View, CA18 hours ago- ...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...
- ...LATAM markets (including Chile and Argentina), reporting directly to the Head of Compliance, Global Payment. Lead and execute the region’s regulatory and licensing strategy, including applications (IFPE, Regulated SOFOM, EMI, SCD, etc.), renewals, and ongoing...Local area
TikTok
San Jose, CA18 hours ago $120k - $145k
...The Regulatory Affairs Manager is responsible for monitoring, interpreting, and influencing regulatory and standards requirements that impact... ...recommendations for senior leadership. Coordinate and execute legislative lobbying activities, including management of contract...Contract workWork experience placementWork at officeDaikin
Santa Clara, CA1 day ago- ...Regulatory Affairs Manager The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission...
AstraZeneca
Santa Clara, CA1 day ago - ...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-...
Confidential
San Jose, CA1 day ago - ...Job Title Responsibilities: Regulatory submissions including original ANDAs, amendments, annual reports, supplements and... ...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, CA4 days ago $170k - $250k
...Regulatory Compliance Director At Arlo, we're passionate about creating innovative and reliable solutions that help people protect what matters... ...matters, providing expert guidance and maintaining strong executive-level relationships. Serve as Arlo's primary point of contact...Work at officeArlo Inc
Milpitas, CA1 day ago- ...Job Summary This Regulatory Affairs Manager position is an onsite opportunity. The candidate will combine knowledge of scientific, regulatory... ...manufacturing changes for regulatory filing strategies. Execute and manage technical and scientific regulatory activities....Work experience placement
Gateway Recruiting
San Jose, CA3 days ago - ...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
Confidential
San Jose, CA1 day 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...
Confidential
Santa Clara, CA18 hours ago - ...tourism insights About the Role The Company is seeking a Director, Chief of Staff, and Business Operations to play a pivotal... ...advisor to the CEO, driving strategic initiatives, and ensuring the executive team remains aligned and focused on high-impact opportunities....
- ...VP or Senior Director, Corporate Strategy and M&A San Diego, California, United States or China (Shenzhen, or Shanghai, or ChengDu... ...communication skills and ability to articulate insights to Senior Executives, President and CEO. Responsibility: Analyze existing...
Lloyd Morgan Hong Kong Limited
San Jose, CA10 hours ago $236k - $412k
...Req ID: JR104064 Managing Director, MU Ventures Our vision is to transform how the world uses information to enrich life for all.... ...sourcing, diligence, valuation, structuring, negotiation, and executive-level investment recommendations. The role will also partner closely...Full timeLocal areaRelocationShift workMicron Technology
San Jose, CA4 days ago$190k - $225k
...residents and for our team members. We’re looking for an Executive Director (ED) to lead The Terraces at Los Altos (TLA), a vibrant Life... ...regulations that may impact Community operations and ensures regulatory compliance; directs all records/reports required by...Full timeLocal areaThe Terraces at Los Altos - a HumanGood community
Cupertino, CAa month ago- ...within the Internal Audit/SOX department, reporting to the Senior Director, Internal Audit and SOX. The continued growth of our business... ...the company. The ideal candidate will ensure the timely execution of the SOX program, including aiding 0process improvement activities...Hourly payWork at officeLocal areaVisa sponsorshipRelocation packageShift work2 days per week
ESR Healthcare
San Jose, CA18 hours ago $162k - $188k
...antitrust/anti-monopoly/anti-unfair competition, and other legal and regulatory areas. The Compliance Manager will assist in overseeing the... ...and company standards. Contribute to the development and execution of plans to address remediation efforts and testing review findings...Worldwide$162k - $188k
...Corporate Compliance Manager to drive the strategy and daily execution of our global compliance program. In this high-impact role, you... ...interest policies, and global anti‑fraud protocols. Anti‑Fraud & Regulatory Frameworks: Maintain comprehensive compliance frameworks...Worldwide$150k - $190k
...Support SOX compliance reviews and ensure control environments meet regulatory and internal requirements. Partner with business and... ...verbal communication skills with the ability to effectively engage executive and operational stakeholders. Compensation for the IT Audit &...Piper Companies
San Jose, CA1 day ago$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 timePart timeWork at officeWorldwideBloom Energy
San Jose, CA2 days ago- ...President, Chief Officer, Vice President, Director About the Company High-growth digital businesses seeking AI-driven operators... ...systems, analyzing data for commercial decisions, and supporting execution across various business functions. The successful candidate...Casual work
- ...operations, customer service for both B2B customers and B2C users, and regulatory compliance The ideal candidate is a seasoned operator with a... ...Thinking & Collaboration: Experience designing and executing long-term operational strategies that align with overall corporate...Full timeLocal area
Olyns Inc.
Santa Clara, CA2 days ago - ...candidate will be responsible for leading and maintaining the firm's regulatory compliance program, serving as the primary liaison for... ...instrumental in shaping the compliance strategy, partnering with executive leadership, and preparing the organization for regulatory...
- ...maintaining annual corporate risk assessments, and developing and executing AML and sanctions training programs. The role also involves... ..., and ensuring that all products and services comply with the regulatory landscape. Applicants for the Chief Compliance Officer...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Regulatory Affairs. Be the first to apply!
- technical executive San Jose, CA
- healthcare executive San Jose, CA
- ceo San Jose, CA
- nonprofit board member San Jose, CA
- college president San Jose, CA
- hospital ceo San Jose, CA
- information technology executive San Jose, CA
- executive support San Jose, CA
- nonprofit executive San Jose, CA
- executive security San Jose, CA