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
$110k - $143k
Sorren Assurance Manager Our Firm Sorren is a top 50 national advisory firm that blends deep expertise with a human-first approach. We don't just work with numbers—we work with people, building lasting relationships and delivering strategic solutions in accounting, ...SuggestedFull timeSorren
Bend, OR2 days ago- ...Executive Director About the Company Well-established cancer research fund Industry Financial Services Type Non Profit Founded 2015 Employees 1-10 About the Role The Company is seeking an Executive Director to lead its...Suggested
Confidential
Bend, OR2 days ago - ...Executive Director We are Regency Village at Bend, centrally located in beautiful Bend, OR. We are a retirement and assisted living community providing each individual compassionate care in a nurturing environment. We are looking for caring and compassionate individuals...Suggested
Park View Estates
Bend, OR8 hours ago - ...Managing Director, Major Gifts About the Company Pioneering organization advancing the Technion-Israel Institute of Technology... ...CRM systems, is highly valued. Hiring Manager Title Chief Executive Officer (CEO) Functions ~ Non-Profit Management...SuggestedLocal area
- ...& Girls Clubs of Bend (BGCB). Reporting directly to the Chief Executive Officer (CEO), the COO will oversee facilities, safety, finance... ...transparent reporting and strategic updates to the Board of Directors. Qualifications Proven ability to build and lead large...SuggestedLocal area
Boys & Girls Clubs of America
Bend, OR4 days ago $85k - $95k
...new opportunities for associate who are passionate about serving seniors and making a difference every day. As the Associate Executive Director at Mt. Bachelor Assisted Living and Memory Care , you'll assume administrative authority in tandem with the Executive...Full timeImmediate startFlexible hoursWeekend work$220k - $245k
...define product requirements, user stories, and acceptance criteria, ensuring alignment with customer needs and business objectives. Execution: Lead agile development processes, prioritize features, and ensure the successful delivery of products, all while collaborating...Remote work- St. Charles Health System Inc. in Bend, Oregon, seeks an RN Case Manager to provide essential case management and support for patient care. The role involves collaborating with healthcare teams to create and implement discharge plans, ensuring patients receive effective...Full time
$130k - $188k
...Provide guidance and support to the President and Board of Directors on areas of responsibility as needed and requested. Fiscal Leadership... ...Resources at 541.383.7216 or the Vice President for Student Affairs at 541.383.7211. This policy covers nondiscrimination in...Temporary workLocal area- ...Job Description Job Description Managing Director | WealthBridge WealthBridge Financial Group is seeking a proven financial advisor for a strategic Managing Director . This role is ideal for an experienced advisor who has successfully built a personal practice...Visa sponsorship
- ...energy independence for communities and nations everywhere. The Director, Digital Marketing & Web Strategy will lead Quaise's digital... ..., investor-facing teams, recruiting, technical teams, and executive leadership, the Director will develop and execute scalable digital...Remote work
- ...Description Serán is seeking a QA Associate Director,who oversees the day-to-day operations... ...creative teams, and improve, adapt, and execute practical solutions in competitive and... ...internal audits, client audits and regulatory inspections Required Skills and Experience...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Regulatory Affairs. Be the first to apply!
