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
- ...Senior Executive Director, Regulatory Affairs About the Company Well-funded clinical-stage biotech company Industry Biotechnology Type Privately Held About the Role The Company is seeking a Senior Executive Director for Regulatory Affairs...Suggested
Confidential
Portland, OR1 day ago - ...Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles Industry Retail Type Privately Held About the Role The Senior Director, Regulatory Affairs will be responsible for developing...SuggestedWorldwide
Confidential
Portland, OR1 day ago - ...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
- The VA Portland Health Care System (VAPORHCS) in Portland, Oregon is seeking an experienced and dynamic leader to join our team as the Chief of Radiology/Imaging . The Chief will work closely with the Imaging Administrative Officer and the Chief Technologist to form the...SuggestedFull timeLocal areaMonday to FridayFlexible hours
- ...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
Gresham, OR2 days ago - Job Description The Portland VA Medical Center in Portland OR is currently seeking a dynamic and proven leader to join our team as the Service Chief of Geriatrics & Palliative Care within the Rehabilitation and Long-Term Care Division. The Service Chief must be board...
Veterans Health Administration
Portland, OR28 days ago - Job Description The VA Portland Health Care System (VAPORHCS) in Portland, Oregon is seeking an experienced and dynamic leader to join our team as the Chief of Radiology/Imaging . The Chief will work closely with the Imaging Administrative Officer and the Chief Technologist...Local area
Veterans Health Administration
Portland, OR5 days ago - ...people strategy for a complex, multi-brand, multi-state organization at a pivotal stage of growth. You'll work directly alongside the executive team to build the culture, structure, and talent engine that allows InterDent to become the employer of choice across every market...
InterDent Service Corporation
Gresham, OR3 days ago - The Gresham Area Chamber of Commerce and Visitors Center is seeking a Loan Servicing Supervisor/Officer to manage the Loan Servicing Department. This role involves developing procedures, ensuring compliance with regulations, and coordinating department efficiency. The ideal...
- ...maturing an enterprise compliance program, translating legal and regulatory requirements into operational guidance, and leading the legal... ...function with a focus on scaling and development. This executive position requires a candidate with over 10 years' of progressive...
Confidential
Portland, OR1 day ago - ...Chief Executive Officer (CEO) and Chief Operating Officer (COO) About the Company Well-regarded independent company in the FMCG & CPG sectors Industry Food & Beverages Type Privately Held About the Role The Company is in search of a dynamic and visionary...Worldwide
- ...and maintenance of the firm’s compliance program. The position is also responsible for preparation and submission of the firm’s regulatory filings and the preparation of the firm’s client services agreements. The position also oversees the firm’s human resources function...
Multnomah Group, Inc.
Portland, OR14 hours ago - ...Title: Compliance Manager Department: Administrative Reports To: Director of Risk & Compliance Work Type: Hybrid Classification: Full-... ...Job Duties Monitor and interpret federal, state, and local regulatory requirements affecting health center operations. Develop, maintain...Full timeWork at officeLocal areaMonday to FridayFlexible hours
Neighborhood Health Center
Portland, OR3 hours ago - ...About the Role The Company is in search of a Chief of Staff with a focus on strategy and operations to join their team. This executive leadership role is pivotal in driving the company's strategy, enhancing operational execution, and ensuring the alignment and efficiency...
- ...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
- ...About the Role The Company is in search of a Chief of Staff with a focus on strategy and operations to join their team. This executive leadership role is pivotal in driving the company's strategy, enhancing operational execution, and ensuring the alignment and efficiency...
- ...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-...
- ...tourism insights About the Role The Company is seeking a Director, Chief of Staff, and Business Operations to play a pivotal... ...advisor to the CEO, driving strategic initiatives, and ensuring the executive team remains aligned and focused on high-impact opportunities....
$143.78k - $267.02k
...Environmental Science and Compliance. This role involves managing teams focused on environmental compliance and permits while overseeing regulatory strategies and ensuring that all environmental obligations are met in a cost-effective manner. Candidates should possess...$60k - $70k
Bonaventure of Gresham is Seeking an Engaged and Dedicated Assistant Executive Director Salary from $60,000 to $70,000 No senior living experience... ...and is critical to leading the community to financial, regulatory, and operational success. In this role, you will be...Work at officeImmediate startFlexible hours- ...Head of Global Regulatory Advertising and Promotion About the Company Industry shaping biopharmaceutical company Industry... ...Regulatory Advertising and Promotion to lead the development and execution of the global regulatory strategy for advertising and promotion...
$30 - $38 per hour
...project control, construction staking and verification. Work collaboratively as part of a team and independently when required. Execute project scope and complete assigned tasks accurately, efficiently, and within established schedule and budget. Train, mentor,...Hourly payFor contractorsWork at officeLocal areaImmediate startRemote workRelocationRelocation packageLong distanceNight shiftOtak
Portland, OR3 days ago- Safety Manager Safety Manager - Lead Safety. Protect People. Drive Culture. Competitive Pay Day 1 Benefits Career Growth Meaningful Impact Are you a safety leader who thrives on preventing risks before they happen? Do you want to play a mission-critical role in protecting...
Aspire Talent Solutions
Portland, OR14 hours ago - ...Head of Policy and Regulatory Affairs About the Company Innovative layer 1 blockchain technology company Industry Information... ...the Web3 ecosystem. This role involves the development and execution of policy strategies, as well as engaging with industry...
Confidential
Portland, OR1 day ago - ...the Board Member position at the company should be accomplished executives with a proven track record in their respective fields. The... ...other board members to support the company's mission and objectives. Functions ~ Board of Directors (non-operating)...
Confidential
Portland, OR1 day 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
Portland, OR3 hours ago - ...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
Portland, OR1 day ago $143.2 per hour
...Joint Commission, Centers for Medicare and Medicaid and other regulatory bodies. Experience in cultivating external partnerships to define... ...levels of the organization, including the CEO and the Senior Executive team, hospital and clinic administrators, board committees,...Jobleads-US
Portland, OR1 day ago- Job Description Job Description Job Opportunity: Chief of Radiology/Imaging Our organization in Portland, Oregon, is on the lookout for a skilled and proactive leader to fill the role of Chief of Radiology/Imaging. This position involves close collaboration with the...Full timeLocal areaMonday to FridayFlexible hours
Department of Veterans Affairs
Portland, OR6 days ago - ...Founded 1984 Employees 1-10 About the Role The Company is seeking visionary, strategic leaders to join its Board of Directors and help shape the future of global behavioral health. This is a legacy opportunity to directly influence international standards,...
Confidential
Portland, OR3 hours ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Regulatory Affairs. Be the first to apply!
