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
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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,...
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$150k - $195k
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...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- ...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
$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$132k - $172k
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...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$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 CMC regulatory strategies to support clinical development...Full timeTemporary workRemote 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...
$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$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$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
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...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
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