VP, US Regulatory Affairs Rare Disease Strategy Leader
ITF Therapeutics LLC
ITF Therapeutics LLC in Concord, MA is seeking a Vice President of Regulatory Affairs to lead US regulatory strategy for the rare disease portfolio, manage FDA interactions, and ensure post-market safety reporting.
This executive will build and lead the US Regulatory Affairs organization, collaborate with Global Regulatory Affairs, and advise on lifecycle management, submissions (INDs/NDAs), and cross-functional risk planning.
#J-18808-Ljbffr- ...President, Head of US Medical Affairs, Rare DiseaseIpsen is a... ...: Oncology, Rare Disease and Neuroscience.... ...medical vision, strategy and execution... ...partnered assets.The VP acts as the senior U.S. medical leader and strategic... ...Medical Affairs, R&D, Regulatory, Commercial,...Suggested
$330k - $370k
...Vice President Of Regulatory AffairsReports... ...of Regulatory Affairs is a senior... ...developing all US regulatory activities... ...Therapeutics' rare disease portfolio,... ...US regulatory strategy, manage all FDA... ...an organization leader and be a steward... ...as partner with VP Global Regulatory...SuggestedLocal areaWorldwide- ...Ipsen Cambridge (US) seeks an Associate Director, Operations for the Rare Disease Business Unit to bridge the home office and field teams, ensuring alignment and... ...strategic priorities. You will partner with senior sales leaders to enhance field engagement and drive cross-...SuggestedHome office
- ...Title:Director, Key Opinion Leader Marketing, Rare Disease Company:Ipsen... ...the company’s success. Join us on our journey towards sustainable... ...the peer-to-peer engagement strategy across the portfolio. This... ...understanding of medical, legal, and regulatory (MLR) requirements...SuggestedWork at officeLocal area
- ...seeks a Vice President, Compliance to develop and manage the Corporate Compliance Program. The role entails crafting compliance strategies aligned with business goals, ensuring adherence to legal standards, and promoting a culture of ethics. The ideal candidate will have...Suggested
$313k - $348k
...each targeting a disease with well-... ...development and regulatory path, and each... ...President, Regulatory Affairs will report to... ...closely with leaders across Research... ...global strategy from early development... ...compliance across US, EU, and other... ...therapy, and rare/genetic disease...Full timeContract workTemporary work$230k - $346k
...years in our networks in the US and the UK, with a range... ...around $25bn. Our strategy is focussed on delivering... ...are now recruiting for a VP US Policy & Regulatory Strategy, to be responsible... ...Reporting to the SVP-US External Affairs, the leader of this function will work...Work experience placementLocal areaShift work- ...atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy... .... As a global leader in myostatin biology... ...President, Head of Regulatory Strategy, reporting to the SVP... ...Head of Regulatory Affairs, is accountable for... ...deep understanding of US/EU regulatory...Work at officeLocal areaShift work
$307k - $325.35k
...ophthalmological diseases. Founded in 2016,... ...President, Program Team Leader is the single... ...accountability for the strategy, value creation,... ...clinical, regulatory, CMC, nonclinical,... ...allogeneic platforms. Rare disease, orphan,... ...workplace. Please let us know if you...WorldwideShift work$319.06k - $389.97k
...life-threatening diseases. Beyond our... ...are counting on us to make the promise... ...leader and executive sponsor... ...ensures sustained regulatory compliance and... ...Manufacturing, Regulatory Affairs, and Commercial... ...Enterprise QMS Strategy & VisionDefine... ..., specialized, rare or in-demand...Full time$267k - $377k
...range of debilitating diseases.Summary:Biogen is... ...talented marketing leader for the role of Executive Director, US EMPAVELI Brand Lead... ...in ultra rare disease (PNH, C3G,... ...development of brand strategy in partnership with... ...compliance, legal, and regulatory are in place to support...Temporary workSummer workWork at officeLocal areaHome officeFlexible hoursAfternoon shift3 days per week$309k - $399k
...the lives of patients. Join us in making the impossible possible... ..., Advertising and Promotion Regulatory Affairs will report to the Senior... ...regulatory and labeling strategy to enable the US business to... ...and FDA. Experience in a rare disease is essential and gene therapy...Minimum wageLocal areaFlexible hours$228k - $313.5k
...approaches to serious diseases with unmet... ...-level CMC strategy and execution across... .... This leader will be equally... ...Development and Regulatory CMC. Accountability... ...partnership with VP, CMC Operations... ...and Regulatory Affairs to establish... ...process that enables us to innovate and...Contract work$206.25k - $297.92k
...Real World Evidence Strategy LeadLocation:... ...evidence that drives regulatory, access and medical... ...- enables us to invent medicines... ...alignment with the global disease area strategy;... ...experience in Immunology, Rare Diseases, Oncology... ...as well as senior leaders through personal...Full timeLocal area$148.5k - $214.5k
Job title: US Neurology and Immunology... ..., oncology, rare blood disorders and rare diseases. Sanofi's... ...be the industry leader in immunology.... ...with U.S. Medical Affairs/Value & Access... ...based contracting strategies, etc.Set HEOR... ...the legal and regulatory environment of...Full timeContract work- ...disorders. Based in Cambridge, US and Copenhagen, Denmark... ...and collaborative leader to serve as Vice... ...and guide Hemab’s safety strategy in collaboration with internal... ...of global regulatory requirements, and the ability... ...with Clinical, Medical Affairs, Regulatory, Quality, Biometrics...
$294k - $318k
Department: 1310US - Regulatory - USLocation:... ...neuromuscular diseases. We are developing... ...at , and follow us on X, LinkedIn... ...Director, Regulatory Affairs serves as a visionary leader who shapes long-... ...regulatory strategy, collaborates on... ...designations for rare muscle diseases,...Local area$224.9k - $404.6k
...The Role The INT Finance Strategy & Integration Leader will serve as a senior Finance leader for INT and... ...teamwork, and direct mentorship. Join us in shaping a world where every... ...routes of administration, for serious diseases that are not treatable today. Third...Temporary workWork at officeWork from home- ...is seeking a Medical Director to lead the Sickle Cell Disease (SCD) program within US Medical Affairs-Hematology-Endocrine. The role provides medical... ...expertise for the SCD portfolio. You will establish thought leader relationships, support medical initiatives and...
- ...Cambridge, MA is seeking an Associate Director of Regulatory Data Management & Intelligence to define data strategy, governance, and the digital data ecosystem... ...dashboards with Tableau. Collaboration across Regulatory Affairs, Operations, CMC, and Digital is essential. #J-...
$235k - $335k
...deploying TPD to address disease targets and pathways... ...visit or follow us on X (formerly Twitter... ...Executive Director, AI Strategy & Applications to... ...s first dedicated AI leader. Reporting to the VP, Information Technology... ...Clinical Development, Regulatory/CMC, and G&A to turn...- ...seeking a Systemic Mastocytosis/Emerging Indication HEOR Strategy Specialist to lead US-focused HEOR for AYVAKIT and new assets. You will design... ...and reimbursement. This role partners with US Medical Affairs, Value & Access, and Policy teams, translating global evidence...
- ...Sanofi in Cambridge, MA is seeking a Statistical Project Leader to steer statistical leadership for one or more late-phase rare disease projects. You will guide trial design, analysis plans, and regulatory interactions, while mentoring junior statisticians and collaborating...
- ...global biopharmaceutical company is looking for an Associate Director, Incentive Compensation to oversee incentive programs for its Rare Disease and Value and Access Business Units. This role requires at least 6 years of experience in the life sciences industry and 4 years...
$150k - $180k
...Senior Manager, Regional Regulatory Lead – US HematologyCSL Research & DevelopmentLocation... ...to join Global Regulatory Strategy (GRS) within Global Regulatory Affairs (GRA). This individual will contribute... ...is a global biotherapeutics leader driven by our promise to save...Worldwide3 days per week- Biogen is seeking a Nephrology Associate Medical Director to lead US Medical Affairs strategy for C3G and IC-MPGN, aligning advisory boards, data generation and education across nephrology. The role partners with Field Medical, HEOR, and global teams to advance medical...
- ...BlueRock Therapeutics is seeking a Senior Director/VP, Program Team Leader to own the asset strategy and delivery for a priority cell-therapy program, initially focused on Parkinson’s disease. The role requires a proven drug developer who can lead across science, operations...
$349k - $399k
...potential for disease modification in... ...establish and lead the strategy and execution... ...assets in rare central nervous... ...executive leadership, regulatory authorities,... ...functional leaders, fostering a culture... ..., regulatory affairs, CMC, program... ...counting on us. We embrace diversity...Contract workTemporary work$275k - $325k
...consumer-first strategies for obesity and... ...As Head of US Consumer (Metabolic... ...Partner with Medical Affairs to develop pre‑... ...with Medical, Regulatory, Market Access,... ...and DTC leader with a track record... ...broad range of disease areas. We have... ...: obesity, rare diseases, chronic...- ...Pharmaceuticals U.S.A., Inc. in Cambridge, MA is seeking a Director, US Medical Strategy- GI to lead product medical strategy and lifecycle planning... .... The role requires close partnership with US Medical Affairs and cross-functional teams to advance scientific insights...
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