Regulatory Affairs Senior Project Lead - NDA Submissions
Anika
Anika is seeking an experienced Regulatory Affairs Project Manager/Sr. Manager in the United States to lead cross-functional regulatory programs across pharma, biotech, and medical device products. The role focuses on regulatory planning, submission readiness, and program coordination, partnering with Regulatory Affairs, Quality, Clinical, CMC, Manufacturing, R&D, and Commercial teams. The ideal candidate has deep NDA knowledge, CMC expertise, and strong project-management skills to ensure
#J-18808-Ljbffr- Anika Therapeutics, Bedford, MA, is seeking an Regulatory Affairs Project Manager/Sr. Manager to lead cross-functional regulatory programs for pharma, biotech... ...products. You will plan, execute, and coordinate NDA submissions, CMC activities, and regulatory strategies across...Suggested
- Anika Therapeutics, Inc. seeks a Regulatory Affairs Project Manager/Sr. Manager to lead cross-functional regulatory programs... ...regulatory planning, execution, submission readiness, and program... ...global teams. The role requires NDA experience, CMC knowledge, and strong...Senior
- Relay Therapeutics seeks an experienced Regulatory Project Manager to support planning,... ...portfolio. You will partner with Regulatory Affairs leaders and cross-functional teams to... ...plans and ensure alignment with major submission milestones. In this role you will help...Senior
- Roux Consulting in Burlington, MA is seeking a Project Engineer- Environmental Compliance Specialist to support environmental compliance... ...—with office duties to ensure SWPPP and SPCC plans meet regulatory requirements. You will mentor junior staff, manage scope and budgeting...SeniorWork at office
- What You’ll DoThe Regulatory Affairs Project Manager/Sr. Manager leads and coordinates cross-functional regulatory programs... ...regulatory planning, execution, submission readiness, and program... ...experience with FDA New Drug Application (NDA) filings, and working knowledge...SeniorFull timeImmediate start
- ...solutions in a collaborative environment leading to excellent outcomes. We have... ...a skilled and self-motivated Senior/Principal Regulatory Affairs Specialist to support the BrioVAD®... ...studies and regulatory planning and submission activities. What You’ll Do...Senior
$210k - $300k
The Role:Generate is seeking a Senior Director, Scientific Project Lead, Oncology to lead complex, cross-functional scientific programs from concept... ...unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing...SeniorShift work- Millipore Corporation in Billerica, MA is seeking a Senior Principal Medical Writer to lead end-to-end regulatory documentation development, ensuring scientific... ...regulatory dossiers, collaborate with clinical, regulatory affairs, pharmacovigilance, and statistics, and drive...Senior
- ...Medicine, Inc. is seeking a Senior Manager of Regulatory Operations to plan, coordinate, and drive global submissions across our product pipeline... ...partner with Regulatory Affairs, CMC, Nonclinical, Clinical... .... The role requires strong project management and deep knowledge...Senior
- Beam Therapeutics is seeking a Regulatory Director/Sr. Director Regulatory CMC to lead global regulatory CMC submissions and ensure compliant health authority communications. The role sits within Regulatory and partners with cross-functional teams to shape strategies for...Senior3 days per week1 day per week
- ...Therapeutics seeks a Director or Senior Director of Regulatory CMC to lead global regulatory... ...encompasses CMC regulatory submissions, health authority... ...content for INDs, CTAs, NDA/MAA modules, and regulatory... ...years progressive Regulatory Affairs CMC experience in biotech...Senior
- ...Stoke Therapeutics seeks a Senior Manager of Regulatory Affairs focused on Chemistry, Manufacturing, and Controls... ...global CMC regulatory strategy, leads lifecycle management, and provides... ...2.3 and 3; health authority submissions Background in manufacturing, process...Senior
- ...description:As a part of the Regulatory Affairs team at Azurity, the... ...assigned products/projects and will serve as the... ...Authority (HA) submissions for US and for Canada... ...filings including IND, NDA, ANDA, NDS, DMF for a... ...regulatory support for Senior Leadership Team (SLT)...SeniorLive in
$195k - $330k
...building an industry-leading pipeline of... ...of global regulatory CMC strategies... ...for regulatory submissions, including INDs... ...briefing documents, NDA/MAA modules,... ...CMC guidance to senior leadership regarding... ...the Regulatory Affairs CMC function as... ...and project management skills...Senior$127.9k - $191.8k
...Global Labeling Excellence Lead is responsible for advancing... ...labeling activities within Regulatory Quality Safety (RQS). This... ...and maintain global labeling project plans, submission timelines, and health... ...product labeling, regulatory affairs, regulatory operations, quality...SeniorLocal areaImmediate start- A leading environmental consulting firm located in Burlington, MA is seeking a Project Geologist / Scientist to develop and execute technical solutions. Responsibilities include fieldwork, project management, and mentoring junior staff. The ideal candidate has a relevant...Senior
$178.5k - $257.83k
...breakthroughs.Join our EGDS Biostatistics Oncology team as Senior Statistical Project Leader (Director) and you’ll provide statistical... ...clinical development plans, protocol, SAP, CSR, regulatory documents, studies and submissions activities (when applicable), and provide...SeniorFull time$128.6k - $192.9k
...our team to deliver transformational projects that will benefit future... ...Your OpportunityWe’re looking for a Senior Project Manager / Technical Lead experienced in Conveyance who’s passionate... ...studies; presentations to clients, regulatory agencies, and/or project stakeholdersAssist...SeniorFull timeTemporary workPart timeFor contractorsCasual workWork at officeLocal areaRemote workFlexible hours3 days per week$127k - $172k
...Reimagine Possible”, we are leading the charge toward a... ....DescriptionThe Senior IT Business Analyst,... ...Quality Assurance (QA) and Regulatory Affairs/Regulatory Operations... ...documentation, submissions/labeling support tools... ...practicesOversee mid to large-scale projects: Managing projects...SeniorContract workTemporary workSummer workWork at officeLocal area- ...Generate Biomedicines seeks a Senior Director to lead oncology scientific programs from early discovery through preclinical development. The role combines people management with cross-functional leadership across research, translational, and development teams, requiring...Senior
- Northstar Project & Real Estate Services in Cambridge, MA seeks a Senior Project Manager with an engineering/architecture/ construction management background to deliver... ...Management for lab design projects. You will lead client relationships, manage budgets and schedules...Senior
- Vanasse Hangen Brustlin Inc. in Watertown, MA, seeks a Senior Highway Roadway Project Manager to lead multidisciplinary transportation projects, including roadways, bikeways, and utility design, with strong leadership and client coordination. You will oversee traffic engineering...Senior
- ...Biosciences, Inc. in Cambridge, MA seeks an Associate Director of Regulatory Affairs to lead regulatory strategy and execution for our products and companion diagnostic programs. This senior role owns submissions from strategy through approval and serves as the regulatory...Senior
- Mass General Brigham Incorporated is seeking a Senior Project Manager to independently lead enterprise-wide quality initiatives, reporting to the Administrative Director of Quality and collaborating with the CQO and Enterprise Quality Team. You will manage projects across...Senior
- ...resources.Job DescriptionUS Regulatory Advertising and Promotion (US... ..., to other assigned projects. Essential functions: • Responsible... ...coordinating all aspects of regulatory submissions relevant to assigned... ...level: Mid-Senior LevelIndustry: PharmaceuticalsSeniorFor contractors
- ...Senior/Principal Scientist, MPN Biology, Translational... ...therapeutics from project conception to late... ...and Execution: Lead the design,... ...validation. Regulatory Interaction: Work with regulatory affairs to support the preparation... ...of regulatory submissions, including...SeniorContract work
$154.4k - $242.55k
...knowledge.Job DescriptionJoin Takeda as a Senior/Principal Scientist, Cell Based-... ..., often working independently and leading function teams or projects. Additionally, you play a role in... ...stability testing, comparability, regulatory submissions, and analytical control strategy....SeniorMinimum wageContract workLocal area$201k - $351k
...Global Medical Safety Lead (GSL) and provides strategic... ...patient safety and regulatory compliance. In addition... ...Management and Regulatory Affairs. The successful... ...functional teams and/or projects Expertise in analyzing... ...risk management Prior NDA filing (ISS drafting and...SeniorPrivate practice- Stoke Therapeutics is seeking a Regulatory CMC Senior Manager to contribute to global regulatory strategies... ...Regulatory CMC. The role focuses on leading CMC regulatory strategies for... ...health authority engagement, and global submissions. Location is hybrid/remote in Bedford,...SeniorRemote job
$250k - $273k
...investigational medicines, anchored by its lead product, ARCALYST, the first... ...need it most.We're seeking a Senior Director, Quality Compliance... ..., ensuring alignment with regulatory requirements and industry... ...with CMC, Regulatory Affairs, Clinical, Pharmacovigilance,...SeniorWork at office
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