Executive Director, Regulatory Affairs (Radiopharmaceuticals)
ARTBIO
ARTBIO seeks a Senior Director, Regulatory Affairs to lead regulatory interactions and submissions across clinical-stage radiopharmaceutical programs. You will coordinate medical writing and translate R&D data into compliant regulatory communications, guiding high-quality INDs, amendments, annual reports, and lifecycle submissions. You will partner with Clinical, Medical, CMC, Quality, and other functions to maintain submission narratives, regulatory plans, trackers, and archives, ensuring #J-18808-Ljbffr ARTBIO
- ARTBIO, a pioneering biotech company, seeks a Senior Director of Regulatory Affairs to lead regulatory interactions for clinical-stage radiopharmaceutical programs. You will coordinate medical writing, ensure compliant submissions, and partner with Clinical, Medical, CMC...Suggested
$231.9k - $365k
Job DescriptionOur Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear, timely, and... ...with rigor and professionalism.Position Description:The Executive Director, Regulatory Affairs Liaison reports to the Vice President...SuggestedFull timeFor contractorsLocal areaWorldwideFlexible hours$294k - $318k
Department: 1310US - Regulatory - USLocation: Waltham, MACompany Overview:Dyne Therapeutics is focused on delivering functional... ...follow us on X, LinkedIn and Facebook.Role Summary:The Executive Director, Regulatory Affairs serves as a visionary leader who shapes long-term...SuggestedLocal area- Summary The Senior Director, Regulatory Affairs leads and coordinates regulatory interactions and submission execution for ARTBIO’s clinical-stage radiopharmaceutical programs. This role is primarily responsible for coordinating regulatory medical writing across functions...SuggestedContract work
$268.2k - $402.2k
Job DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical... ...advises senior management on status of global Regulatory Affairs strategies and tactics, procedures and practicesCreates...SuggestedFull timeSummer workLocal areaRemote workFlexible hours2 days per week- ...Executive Director, Regulatory Strategy About the Company Clinical-stage biopharmaceutical company developing innovative, transformational... ...company should have a proven track record in regulatory affairs, with a focus on clinical-stage assets. The role requires...
$177k - $278.08k
...bring life-changing therapies to patients worldwide.The Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global... ...to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees...Minimum wageLocal areaRemote workWorldwide$177k - $278.08k
...organization, and will contribute to the team’s delivery of critical functions as follows: Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead.Represents...Minimum wageLocal areaRemote workWorldwide- ...Medical OfficerPosition SummaryThis individual will lead regulatory strategy and execution for growing clinical-stage oncology pipeline. The role will... ..., work independently, and help build Regulatory Affairs capabilities as the clinical pipeline grows.Key ResponsibilitiesDevelop...2 days per week3 days per week
$180k - $245k
...Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our... ...The ideal candidate will be responsible for developing and executing regulatory strategies that support global product...$210k - $320k
...cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.Position Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing CMC and Quality related health authority agency correspondence...Full timeShift work3 days per week1 day per week$215k - $235k
...embrace these qualities, so if this sounds like you then please read on!About the Role:The Director of Regulatory Affairs is responsible for leading regulatory strategy and execution for Abror’s development programs across the portfolio, spanning preclinical and early...$190.4k - $285.6k
Job DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple... ..., Biology, Pharmacy, Regulatory Affairs, Pharmaceutical Sciences,...Full timeSummer workRemote workFlexible hours2 days per week$195k - $330k
...and heard.How you’ll make an impact:Act as the global regulatory strategy lead for Kymera’s IRF5 degrader program, developing... ...required; advanced degree preferred but not required.Director: 8-10 years of Regulatory Affairs experience. Senior Director: 10-12+ years of...Flexible hours$190.8k - $300.3k
Job DescriptionOur Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear, timely, and... ...activities include, but are not limited to:Report to Executive Director or Associate Vice President, General MedicineOversee the global...Full timeFor contractorsLocal areaWorldwideFlexible hours$242k - $313.5k
...Senior Director, Regulatory Affairs CMC – Small Molecule About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company... ...durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each...Local area2 days per week$170k - $267.5k
..., risk-based, technology-enabled, and aligned with applicable regulatory expectations across jurisdictions. The role partners closely with... ...and scalable. You will help us build resilience and execute day to day deliverables at our best. Join us if making your mark...Full timeTemporary workFlexible hours- ...focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed... ...Partner with process owners to ensure controls are properly executed and operating effectively. Assist with remediation of control...Work at office
- ...Vertex Pharmaceuticals LLC is seeking a Director of Regulatory Affairs CMC in Boston. The role leads a Regulatory CMC team, shaping global strategies for small molecule programs and coordinating Health Authority interactions across development and commercialization....
$152.9k - $283.8k
...Compliance. Responsible for the design and execution of a SEC 206(4)-7 compliance program... ...Investment Adviser Compliance and Regulatory Oversight (50%)Provide compliance and ethical... ...as executive leadership and boards of directors. Must be comfortable working in a...Full timeTemporary workFor contractorsLocal areaFlexible hours- ARTBIO seeks a Senior Director, Regulatory Affairs to lead regulatory interactions and submission execution for our clinical-stage radiopharmaceutical programs. This role coordinates regulatory medical writing across functions to translate research data into compliant,...
$224.9k - $404.6k
...will be responsible for managing a team of CMC experts that prepare and oversee CMC and Quality related agency correspondence and regulatory applications. This position will be required to oversee the product strategy for all the products in their portfolio and lead and...Permanent employmentFull timeWork at officeWork from home$210k - $245k
...therapies designed to selectively expand regulatory T cells and reset the immune system.... ...Medicines is seeking an experienced Director of Regulatory Affairs to serve as the company’s first... ...own global regulatory strategy and execution across Phase 1 and Phase 2 development...Temporary workWork experience placementWork at officeFlexible hours3 days per week- Director, Global Regulatory Affairs — Oncology A growing biopharmaceutical organization is seeking a Director, Global Regulatory Affairs to lead regulatory strategy and execution for oncology development programs. This individual will serve as a strategic regulatory partner...
- We are expanding our regulatory capacity to keep pace with the growing... ...to the VP, Regulatory Affairs, the Global Regulatory Lead will... ...ownership of regulatory strategy and execution for an assigned program,... ...least 2-3 years at the Associate Director level (or 1-2 years at the...Flexible hours
- The Director of Regulatory Affairs provides strategic and operational leadership to the development and commercialization of products for one or more of the Company’s clinical programs. Reporting to the SVP, Regulatory Affairs, the right experienced candidate will be a...
- Sanofi Inc. in the US seeks a Director of US Advertising and Promotion, Global Regulatory Affairs to provide strategic direction and oversight for day-to-day activities of assigned products. You will lead regulatory strategies, liaise with FDA, and mentor staff across cross...
- ...remote East Coast) or Copenhagen, Denmark Reporting to : VP, Regulatory Affairs & Quality About Hemab Hemab is building preventative... ...homes: Cambridge, MA and Copenhagen, Denmark. The role As Director, Regulatory Affairs, you'll shape and deliver global regulatory...Remote work
$231.9k - $365k
...Merck seeks an Executive Director to lead global regulatory strategy for ophthalmology and retinal disease programs in General Medicine. This senior role... ...years drug development experience, majority in regulatory affairs M.D./Ph.D. or PharmD. with 9+ years drug...Worldwide$165.4k
VP & Managing Director, Mid-Sized Pharma Join IQVIA and help drive healthcare forward.IQVIA is a leading global provider of clinical... ...strategic resourcing models to ensure consistent, high-quality execution and sustainable growth. Acting as the senior operational bridge...Full timePart timeImmediate startRemote workWorldwide
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