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
$189k - $246k
...Director, Regulatory Affairs Strategy Be a part of a global team that is inspired to make a difference in the lives of people living with rare... ...Affairs Strategy is responsible for developing and executing global regulatory strategies for Phase 2 and Phase 3 development...SuggestedTemporary workLocal areaRemote workWeekend workTravere
San Diego, CA5 days ago- ...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-Ljbffr...SuggestedFull timeRelocation package
Fernridge Group
San Diego, CA1 day 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 programs...Suggested3 days per weekIntuit
San Diego, CA1 day ago$130k - $250k
Mapp Biopharmaceutical in San Diego is looking for a fully remote Director of Regulatory Affairs. This key role includes ensuring compliance with regulations, developing strategies for product development teams, and coordinating regulatory submissions. The ideal candidate...SuggestedRemote job- 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
$130k - $250k
...Director, Regulatory Affairs FULLY REMOTE Assignment through Temporary Agency - Approximately 6 Months Approximately 40 Hours Per Week... ...(ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure...Full timeTemporary workFor contractorsRemote workMapp Biopharmaceutical Inc
San Diego, CA5 days ago- ...Regulatory Cmc Leadership Role Responsible for the strategic regulatory CMC leadership for assigned commercial products to ensure regulatory... ...: BS/BA degree AND 12+ years experience in Regulatory Affairs in the Pharmaceutical/Biotech industry. Prior project...Contract work
Clinical Dynamix
San Diego, CA3 days 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 Diego, CA3 days ago - The Director of Regulatory Affairs will be based in San Diego, CA. The role includes but is not limited to the development and implementation of regulatory strategies for new product submissions, handling existing product registrations, including variations and renewals...Work experience placementWork at office
- ...are collaborating to bring new therapies to patients in need. The Position The 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...
- ...processes, and programs. As a member of the Executive Team, the VP/CHRO participates in... ...coordinate specific functions. 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
- ...Chief Executive Officer (CEO) About the Company Mission-driven organization focused on climate & energy policy Industry... ...include overseeing the management team, working with the Board of Directors, and partnering with development staff to execute fundraising...
Confidential
Chula Vista, CA1 day ago - ...Managing Director, Major Gifts About the Company Pioneering organization advancing the Technion-Israel Institute of Technology... ..., is highly valued. Hiring Manager Title Chief Executive Officer (CEO) Functions ~ Non-Profit Management...Local area
Confidential
Chula Vista, CA3 days ago - ...families, and public education. The successful candidate will be responsible for providing strategic leadership and vision, setting and executing a clear direction that aligns with the mission of the organization. This role involves deepening member engagement, expanding...Local areaRemote work
Confidential
Chula Vista, CA2 days ago - ...Company is seeking dedicated individuals to join its Board of Directors. The Board is responsible for upholding and ensuring the organization... ...oversight. Board members are also tasked with supporting the Executive Director, evaluating the organization's work, and serving as...Live in
Confidential
Chula Vista, CA3 days ago - ...Executive Director About the Company Established legal association providing community resources & networking opportunities Industry Legal Services Type Non Profit Founded 1938 Employees 1-10 Categories ~ Bar Associations...Local area
Confidential
Chula Vista, CA4 days ago - ...the Role The Company is seeking a President to join their executive leadership team. The successful candidate will be responsible... ...will work closely with other divisional leaders, the finance director, the IT department, and the chief development officer to ensure...
- ...Executive Director About the Company Reputable wildlife sanctuary & animal advocacy organization Industry Non-Profit Organization Management Type Non Profit Founded 1984 Employees 11-50 Specialties rescue sanctuary education and...
- ...Executive Director About the Company Reputable metropolitan planning organization Industry Government Administration Type Government Agency Employees 1-10 About the Role The Company is in search of an Executive Director to lead its regional...
- ...qualified pipeline and revenue. The successful candidate will be responsible for owning the demand-gen to revenue engine, setting and executing the strategy, and working closely with Sales and RevOps to optimize the full funnel. Key goals include building a repeatable, AI-...
Confidential
Chula Vista, CA2 days ago - ...Executive Medical Director About the Company Small, agile development team advancing early-phase immunology and inflammation clinical... ...stakeholders, including clinical operations, biometrics, regulatory, pharmacovigilance, and translational teams. Applicants for...Remote workFlexible hours
Confidential
Chula Vista, CA1 day ago - ...Enterprise About the Role The Company is in search of a Vice President, Artificial Intelligence to lead the definition and execution of a global AI strategy that spans the entire product portfolio and internal operations. This executive will be responsible for...
Confidential
Chula Vista, CA2 days ago - ...Education Skill Assessment Training About the Role The Company is seeking a Vice President of Human Resources to provide executive-level leadership and strategic guidance for its human resources operations. The successful candidate will be responsible for...
Confidential
Chula Vista, CA3 days ago - Vice President of Wealth Management About the Company Respected investment advisory firm Industry Financial Services Type Privately Held About the Role The Company is in search of a VP of Wealth Management to join their team. The successful...
Confidential
Chula Vista, CA3 days ago - ...building the necessary systems and infrastructure to support these activities. The role also involves working closely with boards, executive leadership, and community leaders to foster a culture of philanthropy and ensure that the organization's mission is aligned with...
Confidential
Chula Vista, CA3 days ago - ...and story, particularly in the context of the global health sector. The Chief Growth Officer will be expected to own the vision and execution of scaling donations, with a focus on driving a major influx of capital from high-net-worth donors and building strong, long-term...
- ...candidate will be responsible for all revenue-related functions, including sales, business development, customer success, and deal execution. This hands-on position involves personally leading and closing large, complex deals, and transforming the current sales approach...
- ...responsible for aligning sales, marketing, and customer success to achieve shared goals and a coordinated go-to-market approach. This executive will also be tasked with building, leading, and scaling a national sales organization, setting and executing pipeline, forecasting...Remote work
- ...maturing an enterprise compliance program, translating legal and regulatory requirements into operational guidance, and leading the legal... ...function with a focus on scaling and development. This executive position requires a candidate with over 10 years' of progressive...
Confidential
San Diego, CA2 days ago - ...customer relationships. Applicants for the Vice President of Operations position at the company should have a minimum of 10 years' executive leadership experience in multi-site healthcare operations, with a preference for those in the site management industry or...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Regulatory Affairs. Be the first to apply!
- housing executive Chula Vista, CA
- regulatory law Chula Vista, CA
- regulatory technician Chula Vista, CA
- regulatory contract Chula Vista, CA
- regulatory Chula Vista, CA
- compliance technician Chula Vista, CA
- compliance team leader Chula Vista, CA
- legal compliance Chula Vista, CA
- customs compliance Chula Vista, CA
- compliance Chula Vista, CA