Regulatory Affairs Project Lead - NDA Submissions & MDR
Jobleads-US
Anika Therapeutics, Bedford, MA, is seeking an Regulatory Affairs Project Manager/Sr. Manager to lead cross-functional regulatory programs for pharma, biotech and medical device products.
You will plan, execute, and coordinate NDA submissions, CMC activities, and regulatory strategies across global teams. The role requires strong project management, NDA and CMC knowledge, and the ability to influence without direct authority.
#J-18808-Ljbffr Jobleads-US- What You’ll DoThe Regulatory Affairs Project Manager/Sr. Manager leads and coordinates cross-functional... ...planning, execution, submission readiness, and program coordination... ...New Drug Application (NDA) filings, and working... ...Device Regulation (EU MDR) implementation projects...SuggestedFull timeImmediate start
$210k - $300k
The Role:Generate is seeking a Senior Director, Scientific Project Lead, Oncology to lead complex, cross-functional scientific programs... ...unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to...SuggestedShift work$122.25k - $176.58k
Job title:Project Programming LeadLocation: Morristown, NJAbout the JobAs Project Programming Lead within our Vaccines Biostatistical Sciences team, you'll lead the scientific... ...in CDISC standards (SDTM/ADaM) and regulatory submission requirements.Preferred...SuggestedFull time- ...manufacturing efficiency, and ensure compliance with FDA regulations. You will lead CAPA, NC and QN processes, manage a quality team, collaborate with R&D, manufacturing, and regulatory affairs, and support NPI and product transfers to meet quality standards. Office-...SuggestedWork at office
$148k - $236.5k
...motivated and experienced DMPK project representative to join our... ...preclinical studies, and ensure regulatory readiness. This is a high-... ...decisions and milestones.Design and lead in vitro and in vivo PK/BA/... ...BA sections of regulatory submissions (e.g., INDs, Investigator’s...SuggestedRemote work- Envision Group in Burlington, MA is seeking a Project Manager to join the H2 Center of Excellence (COE) R&D team. You will own the planning, execution, and delivery of hydrogen technology projects spanning electrolyzer development, materials research, system integration...
$35 - $40 per hour
Archadeck in Burlington, Massachusetts, is seeking an Assistant Production Manager to oversee construction projects and ensure high-quality work standards. This full-time role combines fieldwork and office duties in a professional environment. Candidates should have a...Hourly payFull timeWork at office- ...PharmaceuticalsSelling Points Lead impactful clinical... ...innovation in trial management and regulatory submissions.Job DescriptionClinical Operations... ...globally across technical, project management, and regulatory... ...study reports supporting NDA submissions.Clinical Operations...Local area
$195.5k - $293.3k
...US. Your Role: The Compound Operational Lead (COL) is a global strategy program-level... ...that utilize “state-of-the-art” clinical project management methodologies aligned to global... ...nonclinical & pharmaceutical development, regulatory, commercial/ marketing)Location: Billerica...Flexible hours- ...the Operational Team meets our partner's expectations and achieves our high-quality standards. It's the Operations Leader's duty to lead, guide, and inspire the team so that, together, they can evolve in their roles and exceed results. Leadership skills are the key to...
$148.5k - $214.5k
Job Title: RWE Project leadLocation: Morristown, NJAbout The Job:Our Team:Within the... ...translational medicine, commercial and medical affairs, to lead RWE evidence generation addressing... ...clinical development plans, inform regulatory decisions, and support drug positioning...Full timeWork at office$128k - $176k
...OverviewFlagship is seeking an experienced Senior IT Project Leader to drive strategic technology... ..., vendors, and external partners.Lead steering committee meetings, executive updates... ...any source other than candidates. The submission of unsolicited resumes by recruitment or...$148.5k - $214.5k
Job Title: Statistical Project Leader Location: Cambridge,... ...leadership and guidance as the lead statistician on one or... ...development/medical affairs plans, studies and submissions activities (when applicable... ...external stakeholders (e.g. regulatory authorities, medical...Full time- ...Tufts Medicine is a leading integrated health system bringing together the best of academic and community health care to deliver exceptional... ...duties and responsibilities may be assigned. Completes weekly projects as designated by the supervisor. Coordinates all project work...Work experience placementShift workNight shiftWeekend work
$128.6k - $192.9k
...Join our team to deliver transformational projects that will benefit future generations.... ...for a Senior Project Manager / Technical Lead experienced in Conveyance who’s passionate... ...studies; presentations to clients, regulatory agencies, and/or project stakeholdersAssist...Full timeTemporary workPart timeFor contractorsCasual workWork at officeLocal areaRemote workFlexible hours3 days per week- ...public interest. With objectivity and integrity at our core, we lead federally funded research and development centers for U.S. government... ...C2 Platforms department has an immediate need for an Associate Project Lead (APL) for the Survivable Airborne Operations Center (SAOC)...Work experience placementInternshipWork at officeLocal areaImmediate start
$97k - $146k
...Backed by advanced technology, lifecycle services and an industry-leading field organization, we elevate customer performance, turn goals... ...at Johnson ControlsJohnson Controls is seeking a Mechanical Project Team Leader to drive the execution and performance of retrofit...Full timeContract workFor subcontractorLocal area- ...dynamic Field Representative to join their team. This role involves being the eyes and ears on the ground for various energy efficiency projects, from planning through completion. You'll cultivate strong relationships with internal teams, subcontractors, and customers while...For subcontractor
- System High Corporation is seeking an Activity Security Representative III to provide multi-disciplined security support for Collateral, SCI, and SAP programs. The role involves day-to-day security tasks, reviews of inbound/outbound materials, and maintaining logs and databases...
- ...Executive Director of Operations to lead clinical trial management and... ...study planning, execution, regulatory compliance, and cross-... ...teams on data deliverables and submissions Requirements Bachelor's... ...site, multi-national trials and NDA/IND development Track...
$154.4k - $242.55k
...Associate Director, Global Regulatory Project Management and Strategic Planning... ...our Global Regulatory Affairs organization, based remotely... ...with the Global Regulatory Lead (GRL) on Global Regulatory Teams... ...cross functional project submission working groups (SWG) to deliver...Minimum wageFull timeLocal areaRemote workWorldwide- A leading engineering firm in Burlington is seeking a Water/Wastewater Sr. Project Manager to oversee the planning and design of water and wastewater infrastructure projects. The ideal candidate will have over 15 years of relevant experience and a Bachelor's degree in...
- Methods Machine Tools Inc is seeking an ERP Project & Systems Specialist to optimize Infor SyteLine (CSI) while integrating with enterprise data systems and cloud technologies. You will blend ERP expertise with project management, training, and cross-system integration...
- RevBio, Inc. in Lowell, MA seeks an experienced R&D Project Manager to guide medical device development from concept... ...mitigating risks and tracking progress. You will lead design controls, contribute to regulatory filings (IDE, 510(k), PMA), develop test protocols, work...
- Sanofi in Cambridge, MA seeks a Senior Statistical Project Leader (Director) to provide statistical leadership across solid tumor... ...studies. You will guide development plans, protocols, and regulatory submissions, while coordinating multiple complex projects and cross-...
- MilliporeSigma seeks a Director of Global Strategic Projects to identify, scope, and deliver high-impact initiatives within the 10b+ USD... ...ensuring timely execution at a global scale. The role requires leading diverse teams, extensive travel, and strong business and...
$90 - $130 per hour
...Job Title: Project Manager (Medical Devices... ...Approval (PMA) submission of a Class III long... ...manufacturing readiness, and regulatory submission... ..., Regulatory Affairs, Quality, Manufacturing... ...Submission: Lead integrated project... ...standards. Support EU MDR transition...Contract workWork experience placement$110k - $130k
...Project Manager IINova Biomedical is a fast-growing... ...business owners, technical leads, and consulting... ...85, IEC 62304, and EU MDR as they apply to assigned... ...projects. Partner with Regulatory Affairs and Quality on... ...experience with FDA / EU MDR submission familiarity, fluency with...Hourly payWork at officeImmediate startFlexible hours- QualificationsPrimary Duties The Project Coordinator will work closely with R&D PMs to support... ...in the development and management of GRA submission timelines, if appropriate • Prepare legal... ...into electronic management system • Lead or assist with coordinating large meetings...Interim role
- Weston & Sampson is seeking a Project Manager in Wilmington, MA. This role requires at least 5 years of supervision/management experience... ...perform inspections, monitor operating conditions, and ensure regulatory compliance. Join a company that values employee ownership and...
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