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
$130 - $140 per hour
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...companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. THE OPPORTUNITY: Own the worldwide, end-to-end regulatory strategy across multiple therapy areas supporting the Vascular $3B portfolio. Directly...SuggestedPermanent employmentFull timeWorldwideShift work$207.5k - $281k
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...people we love. That's what makes us Roche. At Roche Global Regulatory Affairs we strive to be the world's best Regulatory organization,... ...practices. You contribute to audits by supporting preparation, execution and follow up. You lead the organization to adapt to the...Local areaRelocation packageRoche
Santa Clara, CA2 days ago$162k - $188k
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- ...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
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- ...Group. This strategic leadership role is pivotal in supporting the EVP of Data Center Networking, with a focus on influencing the execution of the company's AI networking strategy. The successful candidate will be responsible for strategic planning, alignment, and execution...
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- ...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-...
- ...Job Title Responsibilities: # Regulatory submissions including Original ANDAs, Amendments, Annual Reports, Supplements... ...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
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...policies and external/internal regulatory requirements. It partners... ...It also leads organizational execution by building strong internal controls... ..., communications or public affairs related position Electric... ...supervision of a manager or director Ability to analyze complex...Contract workWork experience placementWork at officeFlexible hours2 days per week3 days per weekPG&E Corporation
San Jose, CA4 days ago- ## Interconnection and Regulatory Strategy Manager, NAApplylocations: Remote - UStime type: Full timeposted on: Posted Yesterdayjob requisition... ...for supporting Vantage’s data center portfolio through the execution and management of complex commercial energy agreements,...Temporary workLocal areaRemote workFlexible hours
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Confidential
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- ...California is looking for a Chief of Staff to support key initiatives for the Office of the COO. The role will drive organizational execution, lead strategic projects, and ensure effective decision-making processes for the COO. The successful candidate must have excellent...Work at office
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...strategic professional focused on supporting key initiatives for the Office of the COO. 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 employmentWork at office- ...network within the industry. The role requires a strategic thinker with excellent communication skills, the ability to work effectively in a team, and a commitment to the highest ethical standards in business. Functions ~ Board of Directors (non-operating)...
Confidential
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Confidential
San Jose, CA4 days ago - ...role also involves offering legal and regulatory guidance, strategic financial planning,... ...The ideal candidate will have a senior executive background in finance, law, audit, or governance... ...1-1.5 days per month. Functions ~ Board of Directors (non-operating)...Remote work
Confidential
San Jose, CA4 days ago
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