Senior DoD Regulatory Affairs Lead Medical Products
Arcetyp LLC
Arcetyp LLC is seeking a Senior DoD Regulatory Affairs Specialist - Medical Products for an onsite role in Fort Detrick, MD. You will develop and review regulatory strategies for drugs, biologics, blood products, and medical devices, and prepare or review INDs, NDAs, PMAs, 510(k)s, technical files, and clinical evaluation reports. You will also support FDA and other regulatory agency interactions. Minimum qualifications emphasize an in-depth understanding of regulatory requirements across the #J-18808-Ljbffr Arcetyp LLC
$135.62k - $203.44k
...MarylandReports to: Senior Director, Global Regulatory Strategy About Alexion... ...rare diseases. We lead with breakthrough science... ...Manager, Regulatory Affairs US lead will be... ...activities for assigned product(s)/project(s) across... ...diseases and unmet medical needs.This...SeniorMedicalFull timeTemporary workWork at office- Arcetyp LLC is seeking a Senior DoD Regulatory Affairs Specialist - Medical Products for an onsite role in Fort Detrick, MD. The position focuses on regulatory strategy across drugs, biologics, blood products, and medical devices, with responsibilities including IND/NDAs...SeniorMedical
- ...We do not accept corp-to-corp (C2C) candidates. We can't sponsor H1B. Arcetyp LLC is looking for a Senior DoD Regulatory Affairs Specialist - Medical Products . This position is onsite and located in Fort Detrick, MD. ESSENTIAL JOB FUNCTIONS: Develop and review...SeniorMedicalFull timeH1bRemote work
- ...staffing firms. We do not accept corp-to-corp (C2C) candidates. We can't sponsor H1B.Arcetyp LLC is looking for a Senior DoD Medical Product Program Manager / Team Lead. This position is onsite and located in Fort Detrick, MD.ESSENTIAL JOB FUNCTIONS:Lead WRPBH product...SeniorMedicalFull timeH1bRemote work
- .... Arcetyp LLC is looking for a Senior Dod Medical Product Program Manager - Clinical & Regulatory . This position is onsite and located... ...activities. Participate in and lead IPTs/working groups. Support... ...project management. Regulatory affairs and technical documentation....SeniorMedicalFull timeH1b
$135.63k - $203.44k
...Senior Manager leading US regulatory strategy and submissions for rare disease products at Alexion (AstraZeneca). Accountable for developing... ...functional teams on commercial, medical, and business-relevant... ...pharmaceutical regulatory affairs experience in US jurisdiction...SeniorMedical- Arcetyp LLC is seeking a Senior DoD Medical Product Program Manager/Team Lead to oversee DoD medical product programs and lead the WRPBH product management staff at Fort Detrick, MD. This onsite role requires Tier 3 investigation and Secret clearance eligibility, with...SeniorMedical
- Arcetyp LLC is seeking a Senior DoD Medical Product Development Advisor for an on-site role at Fort Detrick, MD. You will provide expert scientific... ..., oversee clinical research strategy, and review regulatory documentation to ensure alignment with DoD requirements. The...SeniorMedical
- Arcetyp LLC is seeking a Blood Products & Transfusion Medicine SME for an onsite... ...Detrick, MD. You will serve as a senior SME in blood products, transfusion... ...related areas, advising on advanced medical product development and regulatory strategies. The position requires subject...SeniorMedicalFull time
- ...week on siteReporting to the Global Medical Head, the Senior Global Medical Affairs Lead, Cardiovascular & Renal is a... ...through Global Medical Team, Global Product Team, and Disease Area Team... ...understanding of healthcare system pathways, regulatory landscapes, market access, and...SeniorMedicalHourly payFull timeTemporary workWorldwide3 days per week
- ...seeking an Associate Director, Rare Disease Product Marketing to shape and execute brand... ...a fast-paced biotech environment. You will lead cross-functional collaboration with Commercial, Medical, Market Access, Regulatory, and R&D to align messaging, generate insights...SeniorMedical
- ...candidates. We can't sponsor H1B.Arcetyp LLC is looking for a Senior DoD Financial Management Lead. This position is onsite and located in Fort Detrick, MD... ..., CCaR, ECAT, TEWLS, and/or PIEE experience.DHA/Army medical acquisition financial management.Experience supporting...SeniorMedicalFull timeH1bWork at officeRemote work
$186.23k - $279.35k
...Boston Reports to: Senior Director, Global Regulatory Strategy About Alexion... ...rare diseases. We lead with breakthrough science... ..., Regulatory Affairs US lead will be accountable... ...assigned project(s)/product(s) and regulatory... ...diseases and unmet medical needs. This individual...MedicalFull timeTemporary workWork at office- ...flexible, organized, and detail-oriented Senior .Net Developer (Multiple Positions) to join... ...and has significant impact on the medical, health, and scientific communities we serve... ...operational support when necessary. Work the product backlog of features and bugs. Provide...SeniorMedicalPermanent employmentContract workLocal areaFlexible hours
- Arcetyp LLC in Fort Detrick, MD is seeking a Senior DoD Medical Product Program Manager / Team Lead to guide WPAC product and program management efforts across development, testing, and stakeholder coordination. The role requires strong leadership of IPTs, experience with...SeniorMedical
- Arcetyp LLC is seeking a Senior DoD Medical Product Program Manager - Clinical & Regulatory for an onsite role at Fort Detrick, MD. The candidate will manage therapeutics, regulatory documentation, and FDA/IRB coordination, with DoD acquisition experience valued and up...SeniorMedical
- Arcetyp LLC is seeking a Senior DoD Medical Product Program Manager / Team Leader for an onsite role in Fort Detrick, MD. You will lead WPAC product/program management activities, coordinate IPTs, and support acquisition strategies, development, and operations to ensure...SeniorMedical
$150k - $175k
...Owner: Chris GlendenningZachary Piper Solutions is seeking a Senior Systems Engineer/Product Owner to support a premier Air Traffic Management program... ...Salary Range: $150,000 - $175,000Comprehensive Benefits: Medical, Dental, Vision, 401(k), PTO, Paid Holidays, and...SeniorMedicalRemote work$150k - $180k
...maintenance seat. Our client is a small medical technology team taking a combination product through FDA clearance and into... ...team. • You are a senior quality engineering manager or quality... ...in manufacturing, including time leading quality engineers. • IQ, OQ, PQ...SeniorMedicalFull timeFor contractorsImmediate startRelocation package- Arcetyp LLC in Bethesda, MD is seeking a Senior DoD Medical Product Development Advisor to provide scientific, medical, and technical expertise... ...to 20%.You will support clinical research strategy, review regulatory documentation, and advise product teams and leadership. A...SeniorMedical
$218.06k - $327.09k
...to set the global regulatory vision for pioneering... ...? This role leads high-impact programs... ...Therapy Regulatory Affairs and act as a franchise... ...with Global Product Teams to align science... ...mitigations to senior leadership to enable... ...including medical, prescription drug...SeniorMedicalHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week- ...AstraZeneca seeks a Senior Global Medical Affairs Lead for its Cardiovascular & Renal therapy area. This executive... ...Design and lead global product and disease area strategies with ambitious... ...Expertise in healthcare system pathways, regulatory landscapes, and external stakeholder...SeniorMedical
- ...moderate and high complexity tests with accuracy and speed in a dynamic cancer-care setting. The role requires a Bachelor’s degree in Medical Technology or related field, state licensure, and five years of experience. Strong QA/QC, phlebotomy, and instrument maintenance...SeniorMedical
- ...performing analyses across Chemistry, Hematology, and Immunology with strict adherence to QA and regulatory standards. Successful applicants will have a Bachelor’s degree in Medical Technology or Clinical Laboratory Science, state licensure as required, and 5 years of...SeniorMedical
- ...Job Description Job Description Senior Director, Global Product Strategy Who We Are Association... ...programs, and event growth strategy. Lead strategic planning discussions and... ...vacation/sick/holiday leave policy, medical, dental and vision health insurance,...SeniorMedicalCasual workLocal areaFlexible hours
$50 per hour
...motivator, innovator, and change agent.Our Lead Senior Tax Accountant in the State Tax... ....-Prepares state tax models to reflect regulatory changes.-Digital Transformation: Ensures... ...extending an offer. Benefits offered: Medical, Dental, Vision, Flexible work arrangements...SeniorMedicalFull timeTemporary workWork experience placementCasual workWork at officeLocal areaFlexible hours- ...can't sponsor H1B. Arcetyp LLC is looking for a Senior DoD Regulatory Affairs SME - Drugs, Biologics & Medical Devices. This position is onsite and located in Fort... ...military-relevant drugs, biologics, blood products, medical devices and other medical solutions. Develop...SeniorMedicalFull timeH1bRemote work
- ...a global nonprofit providing biological materials, seeks a Senior Manager of Product for Primary & Advanced Models in a hybrid role based in Gaithersburg... ...revenue growth and market competitiveness. You will lead cross-functional teams, translate insights into...Senior
- ATCC Biotechnology is seeking a Senior Manager, Product - Cell Models & Reagents to lead the Cell Systems portfolio, including cell lines, media, serum, and reagents. This remote role will own strategy, lifecycle management, and revenue growth while partnering with Operations...SeniorRemote job
- ## Job Details: Senior Manager, Medical/Regulatory WriterFull details of the job.| | ||... ...Remote, US || | Regulatory Affairs || | The Senior Manager,... ...Writer will be accountable for leading and overseeing the medical... ...-in-human studies through product registration. This role...SeniorMedicalFull timeContract workRemote work
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