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
- ...standards, establishing accountability, and driving a culture of compliance that extends to enterprise-wide privacy, cybersecurity, and regulatory change. Applicants must have at least 12 years' of progressive investment management compliance experience, with a strong...Suggested
- ...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
$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- ...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...SuggestedFull time
$236k - $264k
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...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$167.1k - $247.31k
...Marvell, we believe that infrastructure powers progress. That execution is as essential as innovation. That better collaboration builds... .... Partner with counsel on export licensing strategy, regulatory filings, and matters requiring legal advice. Collaborate across...Permanent employmentFull timeInternshipWork at officeRemote workWork from homeShift work$157k - $271.4k
...recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function:... ...searching for the best talent for an Associate Director, Regulatory Affairs to support our Robotics... ..., and LCM activities. Define and execute regulatory strategies for software subsystem...For contractorsLocal areaImmediate startRelocation packageFlexible hours3 days per week6267-Auris Health Inc. Legal Entity
Santa Clara, CA2 days 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- ...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...
- ...essential functions. In addition to other demands, the demands of the job include:Maintaining composure in dealing with authorities, executives, clients and staff, occasionally under conditions of urgency and in pressure situations.May be required to work beyond scheduled...Local areaWeekend work
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San Jose, CA18 hours ago - Join MaritzAt Maritz, decades of innovation and perseverance have built more than just a strong reputation — they've shaped a culture where human connection and collaboration are at the heart of everything we do.Joining Maritz means becoming part of a workplace grounded...Full timeContract workRemote workFlexible hours
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Santa Clara, CA1 day 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...
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San Jose, CA3 days ago $72k - $72.8k
...overseeing programs, policies, and practices. Responsibilities include: 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...Full timeTemporary workPart timeLocal areaApartment Management Consultants
San Jose, CA3 days ago- 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- ...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 $220.3k - $396.5k
...technology itself. We are looking for an exceptional Senior Director of Executive Communications to serve as a trusted strategic advisor,... ...messaging and public disclosures, operating with full fluency in regulatory and public company communications protocols.Work closely...For contractorsWork at officeImmediate startRemote workFlexible hours$161.93k - $269.88k
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...forecasting & planning.Assume responsibility for the overall planning, execution, and success of autonomous driving related projects Actively... ...teams.Ensure that technical work meets customer requirements, regulatory standards, and company quality policies.Ensure that your work...Full time- ...Managing Director, Strategy & AI About the Company U.S.-based professional services firm serving clients across the country.... ...operational leadership. The role involves close collaboration with executive leadership to shape the firm's growth strategy, identify new...
- ...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-...
- ...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...
- ...Senior Director, IT Compliance & Governance (Contractor) About the Company Innovative company designing & developing gene therapeutic products Industry Biotechnology Type Public Company Founded 2013 Employees 51-200 Categories Biotechnology...For contractors
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