VP, Advertising & Regulatory Affairs — Gene Therapy (Lexington)
uniQure Inc.
uniQure seeks a Vice President, Advertising and Promotion Regulatory Affairs to lead US promotional regulatory strategy, ensure FDA compliance, and align labeling with commercial needs. You will be the internal expert on FDA regulations and trends for prescription products including gene therapies.
This senior role requires 12+ years in regulatory affairs, strong leadership, and ability to influence cross‑functional teams.
#J-18808-Ljbffr$309k - $399k
...Description At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet... ...treatments. Role Overview The Vice President, Advertising and Promotion Regulatory Affairs will report to the Senior Vice President Global...SuggestedMinimum wageFull timeLocal areaFlexible hours$290k - $323k
...oncology company bringing the next wave of therapies for cancer patients. The Company’s... ...Responsibilities Lead and/or oversee global regulatory CMC submissions (e.g., INDs, CTAs, BLAs,... ...12 years’ experience in Regulatory Affairs CMC in Pharma/Biotech Strong negotiation...SuggestedFull timeContract workTemporary workFor contractorsFlexible hours$310k - $400k
...assembled a platform with integrated gene editing, delivery and internal... .... Position Overview: The VP, Clinical Development will... ...medical lead for base editing gene therapies in our metabolic franchise and... ...develop integrated clinical/regulatory strategies for key initiatives...SuggestedFull time- ...Bicycle® technology to develop therapies to treat diseases in a range... ...leadership team located in Lexington, Massachusetts, USA. For... ...Development, Operations, and Regulatory Affairs. As a key member of the Development... ...Leadership Team, the VP provides strategic...SuggestedFull timeImmediate startFlexible hours
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$241k - $270k
...the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we provide innovative products... .... Reporting to the Senior Vice President, Quality and Regulatory Affairs, the Vice President, Quality Assurance is responsible for the...Full timeWork at officeRemote workWorldwideFlexible hours2 days per week3 days per week$272k - $340k
..., authentic and committed to our mission of developing therapies that give people the power to transform their lives and... ...considerations across the portfolio Partner closely with Clinical, Regulatory, CMC, and Medical Affairs to ensure Phase3 plans are fully integrated and...Contract workFor contractorsWork at officeLocal areaFlexible hours3 days per week- ...President, Program Management About the Company Innovative biotechnology (BioTech) company specializing in obesity treatment therapies Industry Biotechnology Type Privately Held, VC-backed Founded 2024 Employees 51-200...
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...organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic... ...to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic leadership...Full timeTemporary workLocal areaWorldwide$281k - $344k
...focused on developing and delivering category‑leading precision therapies to transform the lives of people living with autoimmune and... ...can live life fully. Job Summary The Executive Director, Regulatory Affairs will report to the Senior Vice President, Regulatory Affairs...For contractorsLocal areaFlexible hours2 days per week- ...Executive Director, Regulatory Affairs About the Company Innovative biotechnology (BioTech) company specializing in precision therapies for autoimmune & inflammatory diseases Industry Biotechnology Type Privately Held, VC-backed Founded 2025 Employees...
$399.8k - $425.3k
...committed to our mission of developing therapies that give people the power to transform... ...medical community, interact with global regulatory authorities, and work cross-functionally... ...clinical input to regulatory, safety, medical affairs, commercial, payer, and manufacturing...Full timeWork at officeLocal areaRemote workWork from homeRelocationFlexible hours3 days per week- ...Therapeutics Specialties cell therapy autoimmune and lupus... ...disease, neurology, cell and gene therapy, oncology, immunology,... ...therapeutic areas. The VP, Sales will be responsible for... ...while ensuring compliance with regulatory and company requirements. The...
$238k - $374k
...organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic... ...to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination Product, you will provide...Minimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide$260k - $360k
...barriers, together. Opportunity Overview The Vice President, Regulatory Affairs is a senior leader within Rhythm’s Global Regulatory Affairs... ...access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital...Full timeWork at office$241k - $270k
...and pharmaceuticals. Candidates should possess a Bachelor's degree, extensive industry experience, and proven capability in regulatory affairs. The position offers a hybrid work environment and a competitive salary range of $241,000 to $270,000 annually. #J-18808-Ljbffr...Full time- ...executive role serves as the senior clinical leader for quality, regulatory and compliance as well as clinical education, and clinical... ...performance improvement, and business value. Direct reports include VP Clinical Transformation, VP Regulatory and Compliance, VP,...Work from home
$189k - $241.5k
...About Us Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our cytoDRiVE® technology in cell and gene therapy products to control expression of proteins for enhanced therapeutic...Work experience placementRemote work$265k - $397k
...Executive Director, Field Medical Affairs Position Summary: The Executive Director (ED), Field Medical Affairs is a senior leader within... ...courageous science and compassion to develop life‑changing therapies for some of the most challenging diseases patients face. We ushered...Full timeSummer workLocal areaWorldwideFlexible hours2 days per week$256.9k - $406.2k
...renewal, strategy, and enrollment cycles, ensuring programs optimize employee experience, manage costs, and align with regional regulatory requirements. Design Pay for Performance programs, including equity plan design, delivery, and education. Establish governance...Temporary work- ...technology. By developing in vivo CAR-T therapies, Kernal Bio is advancing precision treatments... ...Chemistry, Manufacturing, and Controls (VP of CMC) to lead the development and... ...release testing. Define and execute the CMC regulatory strategy, including authoring IND and CTA...Contract workFlexible hours
- ...We are seeking an experienced and visionary Vice President of Regulatory to lead the strategic development and supply of biopharmaceutical... ...substantial experience considered) 12+ years of regulatory affairs experience in the biopharma/biotech industry, including...Full time
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Beth Israel Lahey Health is hiring a Market Vice President, Philanthropy in Winchester, MA. This role involves advancing fundraising, overseeing multiple hospital initiatives, and managing a team focused on major philanthropic gifts. Candidates should have a bachelor's...Full time$330k - $365k
...Research, the firm in-licenses promising therapies that for some reason are not advancing toward... ...in need. Position Summary The VP of Biometrics and Clinical Analytics will... ...development, operations, translational science, regulatory, quality, and executive leadership to...Full timeInterim roleLocal area$110k - $207.5k
Who we are looking for State Street Alpha Data Service (ADS) is the data-as-a-service provider that is the back bone of the Alpha front to back strategy. Combining both technology and service provision to deliver significant data management value to our clients. We'...Full timeTemporary work- ...Chief of Staff, Operations, Marketing, Advertising & eCommerce About the Company High-growth DTC digital marketplace scaling toward $500MM+ revenue. Industry Retail Type Privately Held About the Role The Company is seeking a Chief of...
- ...Life Science Therapeutics Specialties cell therapy autoimmune and lupus lupus multiple sclerosis systemic... ...development. A strong background in cGMP manufacturing and regulatory requirements for biopharmaceutical products and ATMPs is...Contract workTemporary work
$330k - $375k
...Innovation Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across lupus, IgA... ...Responsibilities Build and/or oversee the foundational Medical Affairs operating model, including insights, medical information,...WorldwideFlexible hoursShift work
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