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
- ...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...Suggested
$189k - $246k
...toward a common goal of elevating science and service for rare patients.Position Summary:The Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory strategies for Phase 2 and Phase 3 development programs to support successful...SuggestedFull timeTemporary workLocal area$240k - $275k
San Diego, CAClinical - Regulatory /Full-Time /HybridThe Senior Director, Global Regulatory Affairs will provide strategic regulatory leadership across Janux’s clinical... ...AND RESPONSIBILITIESLead the development and execution of global regulatory strategies across early-...SuggestedFull timeSummer workWork at officeRemote workRelocationRelocation packageShift work$210k - $230k
...are collaborating to bring new therapies to patients in need. The PositionThe Director of Regulatory Affairs is Arrowhead’s Labeling lead, who drives cross-functional development and execution of global regulatory labeling strategy. This individual will manage...Suggested- Stryker Corporation is looking for a Director of Regulatory Affairs to lead regulatory strategy and compliance efforts. This fully remote position involves coordination with FDA and overseeing regulatory submissions in the pharma/biotech field. Candidates should have extensive...SuggestedRemote job
- ...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...
$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 programs...3 days per week- ...partners, investor relations, finance, and operations teams on regulatory and compliance matters. Oversee compliance policies,... ...environment. Strong judgment, discretion, communication skills, and executive presence. Bachelor's degree required; JD preferred. #J-18808...Full timeRelocation package
$210k - $240k
...research into real-world, safety-critical systems. Senior Director, Regulatory Affairs Location: San Diego, California (Onsite) Department:... ...additional international filings as needed Develop and execute software and firmware regulatory strategy for complex BCI...Full timeTemporary workInternshipFlexible hoursSynchron Inc.
San Diego, CAmore than 2 months ago$220k - $245k
Responsibilities Lead regulatory activities for filing INDs, CTAs, and maintenance activities for open applications, including DSURs,... ...life science with at least 10 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry; PhD degree...- ...and finances companies that develop and commercialize pharmaceutical products. Position Summary The Director, Regulatory Affairs will support the development and execution of domestic and international regulatory strategy for Codera. This position involves planning,...
- ...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
$116k - $151k
...toward a common goal of elevating science and service for rare patients.Position Summary:The Manager, Regulatory Affairs provides regulatory leadership and execution support for late-stage development programs and contributes to the implementation of global regulatory...Full timeContract workTemporary workRemote work$150k - $195k
...service for rare patients.Position Summary:The Associate Director, CMC Regulatory Affairs is responsible for providing strategic and operational... ...commercial programs. This role leads the development and execution of global CMC regulatory strategies to support clinical...Full timeTemporary workRemote work- JOB SUMMARYThe Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) will lead global CMC regulatory strategy and execution across Iambic's development programs. The role will prepare and oversee high-quality CMC content for regulatory...Work at officeFlexible hours
$110k - $150k
...globally.Support and develop internal assessments, risk analysis, and recommendations related to projects, supply chain changes, regulatory updates, and transactional activities.Other duties as assigned.The CandidateMinimum RequirementsHigh School diplomaMinimum of five...Full timeWork at officeLocal area$170k - $300k
...Instagram, and YouTube. Job Description:As the Director of SOX Compliance, you will build, lead,... ...cross-functional influence and executive visibility. As the organization grows, this... ...through successful closure.Monitor regulatory developments and evolving best practices...Full timeTemporary workPart timeWorldwide$132k - $172k
...Department:107000 Regulatory Location: San Diego, USA- Remote Be a part of a global team... ...: The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic... ...programs. This role leads the development and execution of CMC regulatory strategies to support...Full timeTemporary workRemote work$132k - $172k
...for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory... ...commercial programs. This role leads the development and execution of global CMC regulatory strategies to support clinical...Full timeTemporary workRemote workWorldwide- ...processes, and programs. As a member of the Executive Team, the VP/CHRO participates in... ...coordinate specific functions.12. Ensures regulatory compliance with local, state, and national... .... Minimum of seven (7) years of director level or above broad-based human resource...Local areaWeekend work
$246.98k - $299.29k
...lives. Read more: careers.bms.com/working-with-us.The GRS-CMC Director is responsible for overseeing management of multiple development... .... Develop and communicate strategic direction based on global regulatory guidelines and experience. Seeks opportunities for external...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...strategic planning skills. Responsibilities: The CLO ensures the Credit Union’s lending programs align with strategic goals, regulatory compliance, and risk management standards while delivering outstanding member experiences and strengthening our presence in the...Full time
Cutoday USA
San Diego, CA3 days 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...
- ...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...
$258.68k - $313.46k
...personal lives. Read more: careers.bms.com/working-with-us.Sr Director, Global Regulatory Strategy, NeuroscienceWill be a key member of the GRSP... ...or is assigned projects that will impact BMS, regulatory affairs or projects and provides strategies for dealing with them....Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$122k - $212.75k
...for the best talent for Senior Manager, Regulatory Program Management, Immunology.Purpose:The... ...overall global regulatory strategy to executable plans and the coordination of cross-functional... ...) and partners across Global Regulatory Affairs as well as Project Management, Medical...Full timeLocal areaImmediate startWorldwide$228k - $245k
...A biotechnology firm is seeking a Director of Global Regulatory Affairs in San Diego. This role involves developing and executing regulatory strategies to support clinical programs and interaction with global regulatory agencies. Candidates should have a BS in life sciences...Janux Therapeutics
San Diego, CA3 days ago$145k - $165k
...Diego, California. Job Description We are seeking a motivated Regulatory Affairs professional to join our team and help advance the clinical... ...effectively, and can balance strategic thinking with strong execution. Essential duties and responsibilities include the following...Odd jobH1bWork at officeORIC Pharmaceuticals Inc
San Diego, CA15 hours ago$80.05k - $165k
...closure of GRC-related issues in ServiceNow, ensuring timely resolution, appropriate evidence, and alignment with audit, risk, and regulatory expectations.Coordinate SOX IT Audit activities, serving as the primary liaison between audit (internal/external) and technology...Full timeWork at office- ...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....
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Regulatory Affairs. Be the first to apply!
- financial executive San Diego, CA
- executive search company San Diego, CA
- senior manager executive compensation San Diego, CA
- chief dental officer San Diego, CA
- information technology executive San Diego, CA
- store executive San Diego, CA
- nonprofit board member San Diego, CA
- executive leadership development program San Diego, CA
- president San Diego, CA
- chief executive officer ceo San Diego, CA