Global Regulatory Affairs Lead — SaMD & Expansion
Whoop
WHOOP is seeking a Regulatory Affairs Specialist II, Expansion to support global market access for SaMD and wearable health technologies. You will lead international submissions, maintain EU MDR documentation, and coordinate with Notified Bodies and regulators while ensuring product lifecycle compliance. The role is based in our Boston, MA office with potential relocation, and you will partner across functions to drive compliant expansion into new markets worldwide, working closely with product, #J-18808-Ljbffr Whoop
- Verily Health is seeking a Regulatory Compliance Lead to develop and maintain fit-for-purpose... ...consumer, research, and SaMD products, including AI/ML-enabled... ...with an eye toward ex-US expansion. Role requires 5+ years in regulatory affairs within medical devices or digital...Suggested
$177k - $278.08k
...lasting impact on patients worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory... ...such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively...SuggestedMinimum wageTemporary workLocal areaRemote workWorldwide- Moderna is seeking an Associate Director, Global Regulatory Advertising and Promotion to ensure compliance for promotional materials across channels. You will liaise with Regulatory Affairs, Legal, Medical, and Commercial teams to guide advertising and promotional activities...Suggested
- A global pharmaceutical company is seeking an Associate Director for Global Regulatory Affairs. This role involves acting as a Subject Matter Expert and managing all assigned programs while ensuring compliance with advertising and promotion regulations. Candidates should...SuggestedRemote work
- Moderna is seeking an Associate Director for Global Regulatory Advertising and Promotion to ensure... .... You will collaborate with Regulatory Affairs, Legal, Medical, and Commercial teams... ...requirements and APBL guidance. You will lead PMRT/MRC discussions, support FDA...Suggested
- Beeline Medicines in Boston is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for assigned programs. This role reports to the Senior VP, Regulatory Affairs & Quality and will manage global regulatory submissions (IND/CTA/NDA/MAA) and...Worldwide
- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...Remote job
- A public Biotech company in Boston is seeking a Regulatory Affairs CMC Manager/Senior Manager to support biologic products' global development and registration. The ideal candidate will lead the submission of regulatory documentation, ensuring compliance with FDA and EMA...
$170k - $220k
WHOOP is looking for a Staff Regulatory Affairs Associate to shape the regulatory strategy for digital health and AI-enabled technologies. This... ...regulatory approaches for Software as a Medical Device (SaMD) and serving as a primary advisor to cross-functional teams on...$177k - $278.08k
...therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices... ...critical functions as follows: You will be the GRA CMC Franchise Lead for TAK-079 Independently develops the regulatory CMC...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- United States Digital Space LLC in Boston, MA is seeking a Staff Regulatory Affairs Associate to help shape regulatory strategy for SaMD, AI/ML-enabled devices, and wearable health tech. You will partner with Product, Engineering, and AI/ML teams to evaluate regulatory...
- ...Pharmaceuticals Inc. in Boston, MA seeks an experienced Regulatory CMC professional to drive high-quality... ...manufacturing, and controls deliverables. You will support global filing strategies, coordinate with Global Regulatory Affairs, Technical Operations, and Quality, and ensure...
- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for ensuring... ...staff, enhancing their skills and knowledge in regulatory affairs Strong strategic planner with a proven ability to...Full timeLocal area
$174.5k - $274.23k
A leading biotechnology company is seeking a Director, Global Regulatory Lead, GI & Inflammation. The role involves defining global regulatory strategies, leading teams... ..., with a strong background in regulatory affairs. This position is classified as hybrid, offering...- WHOOP is seeking a Staff Regulatory Affairs Associate to shape regulatory strategy for SaMD, AI-enabled technologies, and wearable health solutions. You will partner with Product, Engineering, and AI/ML teams to navigate FDA and EU MDR pathways, provide guidance on model...Work at office
$232.5k - $335.83k
Job Title: Global Brand Lead, Transplant (Solid Organ Transplant)Location: Morristown... ...collaboration with Medical Affairs, Market Access, Corporate Affairs, Digital, Regulatory, and regional commercial... ...brand strategy, portfolio expansion, launch, enterprise wide impact...Full timeLocal area$192.4k - $302.39k
...you to shine? Join us as a Global Medical Lead, PDT Hematology (f/m/x) in... ...Science, Quality, Safety, Regulatory, Manufacturing, and Legal throughout... ...profiling and indication expansion of licensed products.Lead... ...and provide medical affairs and R&D inputs.Planning, designing...Minimum wageTemporary workWork experience placementWork at officeLocal areaRemote work$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies... ...development. As a key member of the Regulatory Affairs team, this individual also contributes to the development...Local areaFlexible hours2 days per week$196k - $269.5k
...preparing for multi-dimensional expansion to reach more patients... ...realize our ambitions, the argenx Global Commercial Team is looking... ...Director, Global Indication Lead, Rheumatology.In this key role... ...understanding of the legal, regulatory and commercial environment across...Full timeTemporary workWork at officeRemote work- ...Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...
$154.4k - $242.55k
...Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived... ...for marketed products and global expansion.Prepares strategic labeling vision... ...promo, regulatory strategy, medical affairs, etc.). 5-7 years of direct experience...Minimum wageTemporary workLocal area$142k - $213k
...Systems and Compliance Lead drives quality excellence... ..., reliability, and regulatory compliance. Responsibilities... ..., and medical device (SaMD) quality, including AI/... ...Verily's QMS; leads expansion to additional certifications... ...or regulatory affairs within the medical device...Full time- Alnylam Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy in Cambridge, Massachusetts. The role involves leading regulatory strategy for CNS programs and facilitating timely submission of regulatory documents to the US. Applicants should have...
- A biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at least 8 years of experience in Regulatory Affairs, particularly with Small Molecule drugs,...
- Northeastern University, Boston campus, seeks a Global Compliance Program Manager to drive the execution of the university's global compliance workplan and projects. The role reports to the Assistant Vice President for Compliance and sits within the Global Compliance Program...
$120k - $225k
Wellington Management Company is seeking a Global Benefits Lead to oversee the operational management of the firm's global benefit programs, particularly US health and welfare and retirement plans. The ideal candidate will have 10+ years of HR/benefits experience and strong...Work from home1 day per week- Sanofi Inc. is seeking a Global Brand Lead for Transplant (Solid Organ Transplant) based... ..., collaborating with Medical Affairs, Market Access, Digital, Regulatory and regional teams to drive global... ...a focus on profitable franchise expansion and external partnerships. #J-18...
- A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical in ensuring compliance and securing... ...with a strong background in regulatory affairs. You will lead multiple teams and oversee...
$111k - $167k
...precise. Description The Regulatory Compliance Lead is a technically grounded individual... ..., and medical device (SaMD) product areas. This role... ...— with an eye toward ex‑US expansion—leveraging tools such as... ...of experience in regulatory affairs within the medical device,...Full time- Wayfair is seeking an International Tax Manager based in Boston. This role will lead the end-to-end US international corporate tax and foreign tax compliance process while managing global tax audits and advising the organization on complex international tax regulations....Work at office
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