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
$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to set the global regulatory direction for first-in-class cell therapies...SuggestedHourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$265k - $285k
...staffingfuture.comResponsibilities include: Provides regulatory leadership in support of the development... ..., Clinical Operations, Medical Affairs, CMC, and Quality to develop, coordinate... ...excellence and successful execution of corporate objectives.Other duties as...Suggested$195.5k - $272.5k
...motivated, self-driven and enthusiastic Director of Regulatory CMC accountable for ensuring all... ...CMC) functional groups and Regulatory Affairs department to plan and lead high quality... ...regulatory leadership to develop and execute sound regulatory strategies that meet...SuggestedFull timeWork at officeWork visa3 days per week- Chief Credit Officer (CCO) About the Company Non-profit organization investing in low income community development Industry Financial Services Type Non Profit Founded 1984 Employees 51-200 Categories ~ Social and Rehabilitation...Suggested
Confidential
San Francisco, CA3 days ago - ...conditions and to provide therapy. We are looking for a Director of Regulatory Affairs and Quality Assurance to help build a business around this... ...role will interact closely with R&D, Clinical, and the executive team. Your work will improve the lives of numerous users...SuggestedFull timeImmediate startWorldwideFlexible hoursNight shift
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...clarity, speed, and quality of work. What You'll Do Lead CMC regulatory strategy and execution across development and post‑approval programs, ensuring... ...; advanced degree preferred. Extensive Regulatory Affairs CMC experience within the biotechnology and/or pharmaceutical...Work at officeRemote workFlexible hours$200k - $250k
...rare and large market indications. Reporting to the Chief Regulatory Officer, the Director, Regulatory Affairs CMC will serve as a key member of the Regulatory organization, responsible for developing and executing global Chemistry, Manufacturing, and Controls (CMC)...- Acadia Pharmaceuticals Inc. is seeking a senior Regulatory Affairs professional to lead advertising and promotional material reviews, ensuring regulatory compliance across our portfolio. You will serve as a key liaison with OPDP, shape labeling strategies, and guide cross...
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...pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Reporting to the Executive Director, Regulatory Affairs, the Senior Director, Regulatory Affairs, REMS Program is responsible for leading regulatory strategy and execution...For contractors$211k - $264k
...with cancers harboring mutations in the RAS signaling pathway. The Opportunity The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation & execution of global regulatory NDA/MAA filings for late-stage oncology programs at RevMed....Full timeWork experience placementLocal area$200k - $300k
...and deepens its engagement with global regulatory bodies, we are building a world-class compliance... ...growth.What you'll doAs the Compliance Director & MLRO, US, you will lead and scale the... ...global FCC leadership team, product executives, and regional business heads to ensure...Temporary workLocal areaWorldwideShift work- ...operations, and data teams to build operationally efficient and effective programsWhat We’re Searching For:3+ years of experience in regulatory compliance, business banking, or commercial cardFamiliarity with vendor management, SOC1, SOC2, risk management and GRC processes...Flexible hours
$160k - $260k
Job DescriptionWhat is the opportunity?This role is responsible for maintaining the firm's Information Barriers to restrict the improper flow of information and prevent the misuse of material non-public information between the public side areas of the firm (e.g., Research...Full timeWork at officeFlexible hoursWeekend work$127k - $165k
...careerAbout This Role:Responsibilities include:Developing and executing regulatory strategies for new and modified medical devices in line with... ...required.> 8-10 years minimum of US and/or EU regulatory affairs experience with a Bachelor’s degree; 6 years minimum of US and...Full timeRemote work- ...Treasury manages liquidity planning across the corporation and its subsidiaries, including our bank and broker-dealers. We monitor regulatory ratios and adherence, and develop associated tools to assist our business partners in analyzing the liquidity impacts of business...Full timeWork experience placement
$172.5k - $222.5k
...responsible for: Circle is looking for a Senior Manager to join the Regulatory Assurance team who will help to create a central global... ...results. What you'll work on: Driving the strategy, framework, and execution of the Regulatory Change Management Program.Identifying and...Flexible hours$275k - $280k
...Position Description: Calico is seeking a Regulatory Director that will be responsible for, in... ...Responsibilities: Accountable to develop and execute the world-wide regulatory strategy for... ...strategies Represent Regulatory Affairs on development teams and support development...Full time$140k - $214k
...clarity, work without fences, and execute with urgency because patients... ...is seeking a Senior Manager, Regulatory CMC to join an experienced,... ...will report to the Senior Director of Regulatory CMC and will be... ...requirements.Represent Regulatory Affairs on cross-functional project...Contract workFor contractorsFlexible hours- ...Job Overview: We are seeking an experienced and highly motivated Regulatory Manager to join our Regulatory Affairs team. In this role, you will be responsible for developing and executing regulatory strategies to ensure compliance and successful product approvals. You...Contract workWork at office
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