Executive Director, Regulatory Affairs Strategy, Cell & Gene Therapy
Confidential
Executive Director, Regulatory Affairs Strategy, Cell & Gene Therapy
About the Company
Respected biopharmaceutical company
Industry
Pharmaceuticals
Type
Public Company
Founded
1999
Employees
10,001+
Categories
- Health and Wellness
- Medical
- Pharmaceuticals
- Biotechnology - See more at:
- Biotechnology and Pharmaceuticals
- Health Care Information Technology
- Pharmaceutical Manufacturing
- User Experience Design
- Ux Designer
- Manufacturing
- Academic Research
- Health Care
- Biotechnology
- International Trade
- Healthcare
- Clinical Care
- Health
- Corporate Citizenship
- Sustainability
- Medicine
- Chemical Products
- Biopharma
- Precision Medicine
Specialties
- pharmaceutical
- biopharmaceutical
- innovation
- research and development
- and global business
Business Classifications
- B2B
- Enterprise
About the Role
The Company is seeking a Senior Director for Regulatory Affairs Strategy in Cell and Gene Therapy. This pivotal role is focused on setting the global regulatory vision for innovative therapies, particularly those targeting cancer, immune-mediated, and rare diseases. The successful candidate will be responsible for leading high-impact programs, guiding them through the regulatory process with a clear and competitive strategy, and ensuring efficient routes to approval that align with the needs of patients, the market, and the business. The role demands a strategic leader who can anticipate risks, seize opportunities, and influence global health authorities. The Senior Director will also be accountable for global regulatory leadership, health authority strategy, and engagement, as well as for the planning and construction of the global dossier and core prescribing information. Applicants for this role at the company should have an advanced degree in a science-related field, with 7-10 years' of experience in regulatory affairs, particularly in the area of cell and gene therapy. A deep understanding of global regulatory science, drug/biologic development processes, and experience in therapeutic areas such as oncology, autoimmune, rare diseases, and neurology are essential. The role requires a proven track record in leading regulatory and cross-functional teams, excellent communication skills, and the ability to think strategically and critically. Experience in leading health authority interactions, as well as a successful history of global regulatory approvals, is also necessary. The ideal candidate will be a strong leader, capable of managing multiple projects, and will have a proactive, flexible approach to work.
Hiring Manager Title
Executive Director
Functions
- Strategy
$280k - $320k
...diseases by silencing the genes that cause them.... ..., Arrowhead therapies trigger the RNA interference... ...present in living cells that inhibits the... ...Vice President, Regulatory Affairs. Executive Director, Regulatory Affairs... ...clinical regulatory strategies and all associated...SuggestedFor contractors- ...Development, Haematology and Cell Therapy About the Company... ...global clinical development strategy across hematology and transplant... ...clinical trials, and leading regulatory strategy and global health authority... ..., as well as providing executive medical oversight of safety,...Suggested
- ...Vice President, Biometrics, Cell Therapy About the Company Rapidly... ...clinical development strategies and guiding the organization... ...statistical aspects of global regulatory interactions and submissions... ...clinical trials, and influencing executive stakeholders. The ideal...Suggested
$181.71k - $299.82k
...University of Southern California is looking for a Senior Director for Cellular and Advanced Therapies to oversee strategic initiatives and operational... ...annually along with extensive responsibilities including regulatory compliance and collaboration to ensure service line...Suggested$210k - $230k
...by silencing the genes that cause them.... ..., Arrowhead therapies trigger the RNA... ...present in living cells that inhibits the... ...Position The Director of Regulatory Affairs is Arrowhead's Labeling... ...development and execution of global regulatory labeling strategy. This individual...Suggested- ...Therapeutics Specialties cell therapy autoimmune and... ...and go-to-market strategy for a groundbreaking... ...tasked with developing and executing the sales strategy,... ..., neurology, cell and gene therapy, oncology,... ...ensuring compliance with regulatory and company...
$180k - $200k
...diseases by silencing the genes that cause them.... ...delivery, Arrowhead therapies trigger the RNA... ...mechanism present in living cells that inhibits the... ...The Associate Director of Regulatory Affairs, Advertising and Promotion... ...on promotional strategy, claims development,...Work at officeLocal area$133.2k - $172.37k
...pioneering personalized CAR T‑cell therapies have changed the... ...and submission of CMC regulatory filings (INDs, CTAs, BLAs... ...Assist in execution of global CMC regulatory strategies under guidance of senior... ...Experience in Regulatory Affairs CMC within biotech or pharmaceutical...Work at officeLocal areaRemote workRelocationFlexible hours- Syneos Health is seeking a VP - Media Strategy in Santa Monica, CA, responsible for leading the Integrated Media Team and developing... ...ideal candidate will drive client relations and ensure impeccable execution of strategies, while managing a growing global team....
$155k - $180k
...Description VP, Integrated Strategy A seasoned strategist who sees the big picture... ...cultivate the careers of direct reports (VPs, Directors, Senior Strategists), fostering a... ...Collaborate with NA Strategy Lead to develop and execute an internal education plan to elevate...Work at officeFlexible hoursSyneos Health/ inVentiv Health Commercial LLC
Santa Monica, CA20 hours ago- ...Senior Executive Director, Regulatory Affairs About the Company Well-funded clinical-stage biotech company Industry Biotechnology Type... ...regulatory activities. This includes global regulatory strategy, managing health authority interactions, and ensuring that...
$150k - $180k
...vaccines, new medicines, and cell and gene therapies. At Cytiva you will be... ...The Global Strategic Account Director is responsible for growth... ...will do: Develop and lead strategy, partnerships and teams... ...accounts. Create and lead executive interactions, collaborations...Remote workNight shiftDanaher Corporation
Los Angeles, CA3 days ago- LE200 Starz Entertainment, LLC is looking for an Executive Director of Social to lead their social-first marketing strategy. The role involves driving audience engagement and cultural impact across key social platforms while managing a dedicated team. The ideal candidate...
$221.64k - $388.36k
...a career in Advisory. KPMG is currently seeking a Director in M&A Services for our KPMG Strategy practice. Responsibilities : As a key advisor... ...business model decisions impact operating model design and execution across operations, technology, risk governance and...Work experience placementH1bLocal areaKPMG
Los Angeles, CA3 days ago$150.01k - $323.38k
...currently seeking a Manager to join our KPMG Strategy practice. Responsibilities : Lead... ...with the engagement Partner, Managing Director or Director to help build relationships... ...impact operating model design and execution across operations, technology, and organizational...Full timeH1bLocal areaKPMG
Los Angeles, CA3 days ago$150.01k - $323.38k
...KPMG is currently seeking a Manager in M&A Services for our KPMG Strategy practice. Responsibilities : Lead engagements and... ...activities by leveraging existing relationships with C-level executives Manage cross-functional project teams and lead team interviews...Odd jobH1bLocal areaKPMG
Los Angeles, CA3 days ago- ...Mental Health Patient Management Specialties ehr therapy notes online appointment scheduling insurance billing... ...translate deep customer understanding into a compelling product strategy, champion the evolution of the platform, and partner with cross...
$365k
...About the Role GoodRx is looking for a Vice President of AI Strategy & Deployment to lead the company-wide effort to embed AI into... ...workflows across the company, with enterprise-wide scope and executive visibility. This is a peer role to Data, ML, Product, and Engineering...Temporary workFixed term contractWork at office- GoodRx is seeking a Vice President of AI Strategy & Deployment to lead the integration of AI across key business workflows. This executive role involves overseeing the company's AI roadmap, ensuring alignment with business priorities, and driving adoption within various...
- ...Revenue to lead total revenue performance across its luxury lifestyle hotels. This senior role involves developing overall revenue strategies, mentoring teams, and driving collaboration among departments to achieve significant commercial success. The ideal candidate will...
$150k - $180k
Syneos Health, Inc. is hiring a VP - Media Strategy to lead their Integrated Media Team in Santa Monica, CA. This role is pivotal in... ...have 12+ years of experience in strategic media planning and execution, with exceptional client management and presentation skills. A...Flexible hours$80k - $90k
...Job Title: Manager, Content Strategy & Library Management Location: Santa Monica, CA, US, 90404 Summary of Position The Manager, Content Strategy & Library Management drives the global coordination and commercial optimization of the studio's film and television library...Work at officeLionsgate
Santa Monica, CA1 day ago$186k - $258.3k
Radiant is seeking a Director of Regulatory Affairs to lead their regulatory and licensing team in El Segundo, CA. This role oversees licensing engagement and strategy with the U.S. Nuclear Regulatory Commission, focusing on the development of the Kaleidos microreactor...$204.73k - $370.53k
...consider a career in Advisory. KPMG is currently seeking a Director, AI Strategy Architect to join our Advisory Services practice.... ...Security, ensuring GenAI deployments comply with emerging regulatory frameworks and enterprise security standards (e.g., implementing...H1bLocal areaKPMG
Los Angeles, CA3 days ago- ...Executive Vice President, Head of YouTube & Social Platforms, Strategy & Operations About the Company Market-leading provider of motion picture production & distribution services Industry Entertainment Type Privately Held, VC-backed Founded 1997...
- ...Chief of Staff, Strategy & Operations About the Company Fast-paced, high-growth organization Industry Facilities Services... ...with a focus on strategy and operations to join their team. This executive leadership role is pivotal in driving the company's strategy,...
- ...Chief of Staff, Strategy and Operations About the Company Fast-growing D2C digital marketplace Industry Retail Type... ...instrumental in optimizing the time, focus, decision-making, and execution of the Senior Leadership Team. The Chief of Staff will be a trusted...Remote work
- ...Chief of Staff, Strategy & Operations About the Company Globally-focused staffing company providing affordable talent solutions... ...with a focus on strategy and operations to join their team. This executive leadership role is pivotal in driving the company's strategy,...
$110k - $130k
Syneos Health, Inc. in Santa Monica is seeking an experienced Social Associate Director to lead advanced social strategy within the integrated media team. This role entails managing and mentoring a team while driving success for social marketing programs. The ideal candidate...$204.5k - $274.2k
Dormont Manufacturing Co is seeking a Director, Partnerships Strategic Planning to lead the strategy for SVOD content partnerships in Santa Monica, CA. This role requires deep expertise in SVOD economics and strong people leadership capabilities. The selected candidate...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Regulatory Affairs Strategy, Cell & Gene Therapy. Be the first to apply!
- chief dental officer Santa Monica, CA
- executive director Santa Monica, CA
- chief executive Santa Monica, CA
- technology executive Santa Monica, CA
- managing director Santa Monica, CA
- talent acquisition executive Santa Monica, CA
- housing executive Santa Monica, CA
- chief executive officer ceo Santa Monica, CA
- chief content officer Santa Monica, CA
- human resources executive Santa Monica, CA