Executive Director, Regulatory Affairs

Confidential

Gresham, OR

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

Apply

Vacancy posted 3 days ago

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