Senior Manager, Life Sciences Regulatory Submissions
EY
Join EY as a Senior Manager in the Life Sciences Regulatory Submissions practice, located in Boston. You will drive growth and be pivotal in establishing EY as a leader in the Regulatory Compliance sector. The role involves leading teams, building client relationships, and developing strategies for regulatory submissions. The ideal candidate will have extensive experience in regulatory compliance within the life sciences sector, with proven leadership capabilities and the ability to implement innovative solutions that align with market needs. #J-18808-Ljbffr EY
- Prometrika, Llc in Cambridge, MA is seeking a Senior Medical Writer to create and edit clinical and scientific reports crucial for regulatory submissions. The ideal candidate will have at least 6 years in medical writing, including 4 years specifically in regulatory scenarios...SeniorRegulatory
$90k - $150k
...advancing brand engagement for the life sciences industry through AI technology. Veeva... ...most. The Role We are hiring a Senior Project Manager, Implementation to join our Client... ...preparing annotations for MLR/PRC regulatory submissions prior to release. Coordinate cross...SeniorRegulatoryLocal areaFlexible hours$216k - $324k
Job Description The Senior Director, Manufacturing Technical Sciences QA is accountable... ...lifecycle management activities. This includes... ...with industry and regulatory expectations, and... ...mitigations throughout the life cycle for the... ...and product submission compliance pre and...SeniorRegulatorySummer workRemote workFlexible hours2 days per week3 days per week$130k - $150k
Praxis Precision Medicines, Inc. is seeking a talented Medical Writer to oversee documents for clinical development programs. This role requires at least 4 years of medical writing experience in a Sponsor or CRO setting, along with a Bachelor’s degree in a scientific discipline...SeniorRegulatoryRemote jobFlexible hours$170k - $210k
...that improve lives. Our smart, science-driven solutions are trusted... ...to shape the future of life sciences. With headquarters... ...Software Quality Assurance Senior Manager leads the software quality organization... ...safety, reliability, and regulatory compliance of software used...SeniorRegulatoryHourly payWork at officeFlexible hours- ...goal is to enable rapid protein access to life science researchers around the world. About... ...role 1. Contract Negotiation & Commercial Management of Lab Services Lead pricing... ...relationship management Ensure compliance with regulatory and procurement requirements 2. Client...SeniorRegulatoryContract workWork at office
- ...biotechnology company is seeking a Pathology Senior Principal Research Scientist in Boston... ...experience. Responsibilities include managing pathology studies, mentoring non-DVM scientists, and participating in regulatory submissions. Competitive salary and benefits offered...SeniorRegulatory
- ...Senior Sales Executive At CI&T, we help large enterprises transform... ...new business within the Life Sciences sector as part of our North... ...digital strategy, product management, technology services, HCP digital... ...of the Life Sciences regulatory environment, including GxP and...SeniorRegulatoryContract workRemote work
$216k - $324k
Dormont Manufacturing Co is seeking a Senior Director, Manufacturing Technical Sciences QA responsible for end-to-end... ...and ensuring compliance with regulatory standards throughout various manufacturing... ...with regulatory agency submissions. The position offers a...SeniorRegulatory3 days per week$175k - $195k
...Grounded in rigorous science and bold... ...led by accomplished life sciences leaders.... ...Reporting to the Senior Director, Brand Marketing... ...Marketing, the Senior Manager, Marketing... ...to manage timely submissions and prioritization... ...medical, legal, and regulatory review team, marketing...SeniorRegulatoryFull timeContract workWork at officeFlexible hours$115k - $170k
...in industry cloud, helping life sciences companies bring therapies to... ...strategy and account management experience in a healthcare/... ...and Veeva Vault PromoMats submissions ~ Track record of managing... ...navigating complex Medical/Legal/Regulatory (MLR) review processes and...SeniorRegulatoryContract workWork at officeLocal areaRemote workWork from homeFlexible hours- 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...SeniorRegulatoryRemote job
- ...a firm. KPMG is currently seeking a Manager or Senior Manager to join our Business Tax Services... ...-related developments, legislative and regulatory changes affecting such individuals and... ...plans, vision coverage, disability and life insurance, 401(k) plans, and a robust...SeniorRegulatoryFull timePrivate practiceWork at officeLocal area
- ...team providing strategic, operational, and people leadership. This role involves developing clinical and regulatory documents and coordinating complex submissions. Applicants should have a Bachelor’s degree and over 5 years of relevant experience in the biotechnology or...SeniorRegulatory
- ...Corporation, Inc. in Cambridge, MA is looking for a Senior Scientist in Toxicology to lead the pre-... ...industry experience. Responsibilities include managing non-GLP/GLP studies and preparing reports for regulatory submissions. Join a dynamic team at an innovative biotechnology...SeniorRegulatory
- ...Cambridge, Massachusetts is seeking a Regulatory Submissions Lead to oversee publishing activities... ..., and more. The ideal candidate will manage submission processes, ensure quality... ...'s or Master's degree in Pharmacy or Life Sciences is required, along with 5-10 years of...SeniorRegulatory
$130.8k - $209.4k
...Role In this role, you will primarily focus on Regulatory Health Authority inspection planning,... ...authority inspections (routine, directed or submission‑driven) and the pre‑inspection request process. Coordinate and manage inspection readiness and preparation activities...SeniorRegulatoryLocal area- ...Biopharmaceuticals Inc. is looking for a Senior Medical Writer in Cambridge,... ...clinical documentation and managing the preparation of regulatory documents for submissions to global health authorities.... ...5 years of experience and a life sciences degree. Ipsen offers a...SeniorRegulatoryFlexible hours
- ...and study reports. This role requires at least 3-5 years of regulatory writing experience in the pharmaceutical industry. The ideal... ...responsible for mentoring team members and ensuring high-quality submissions to regulatory authorities. #J-18808-Ljbffr MMS HoldingsSeniorRegulatoryRemote job
$160k - $200k
Title: Senior Pharmacovigilance Manager Job Summary The Senior Pharmacovigilance... ...representing the affiliate in regulatory and safety matters.... ..., complete, and accurate submissions to health authorities. Maintains... ..., PharmD, MD, or PhD) in life sciences, pharmacy, medicine, or a...SeniorRegulatoryContract workTemporary workLocal area$252k - $269k
...Quality Assurance Senior Leader provides strategic... ..., implements and manages risk-based quality... ...to evolving regulatory expectations. Strategic... ..., NDAs, and other submission related materials.... ...or above in a science discipline. Bachelor’s degree in life sciences, pharmacy...SeniorRegulatoryLocal areaWorldwide- ...development, and commercialization of life‑changing therapeutics for patients in... ...study, X‑TOLE3, which would support regulatory submissions outside the U.S., and the X‑ACKT study... .... About the Role We are seeking a Senior Manager/Associate Director, Access Marketing,...SeniorRegulatoryTemporary workWork at office2 days per week
$250k - $290k
Senior GCP Quality Assurance Lead - Permanent - Boston... ...in compliance with regulatory requirements, ICH... ...Oversee eTMF quality, manage protocol deviations and... ...degree or higher in Life Sciences, Pharmacy, or a... ...contributing to regulatory submissions. Understanding of...SeniorRegulatoryPermanent employmentRemote work$155k - $225k
...its people, cutting-edge science, and a vision of providing life-long cures to patients... ...Overview: Beam is seeking a Senior Manager/Associate Director,... ...clinical study reports, regulatory documents, publications,... ...abstracts. Support regulatory submissions and responses to...SeniorRegulatoryFull time$188k - $200k
...Senior Pharmacy Manager – Boston, MA Trillium Professional is now seeking a Senior Pharmacy Manager in Boston, MA for a direct-hire opportunity... ...setting, with oversight of both clinical workflows and regulatory compliance. This role manages staff, compounding operations...SeniorRegulatory$137k - $215.27k
...Operations Lead and work with Regulatory, Medical, Legal, and... ...teams. The role of Senior Manager, PRAM provides the... ..., Form 2253 submissions, and end-to-end lifecycle... ...ideally in business or science-related concentration... ...you to grow through life‑changing work. Certified...SeniorRegulatoryMinimum wageFull timeTemporary workFor contractorsLocal areaRemote workFlexible hours- ...Getinge is seeking a Sr. Manager, R&D located in Boston, MA, to lead the development of innovative transplant devices that enhance... ...will be responsible for overseeing multiple projects, ensuring regulatory compliance, and managing a team of engineers. A Bachelor's degree...SeniorRegulatoryRemote work
- Apex Systems is looking for a Regulatory Project Coordinator for their biotech client in Cambridge, Massachusetts. This role will support regulatory submissions and project management while collaborating with teams using tools like SharePoint and OneNote. The ideal candidate...Regulatory
- ...looking for a Medical Science Liaison (MSL) in... ...Development, Regulatory Affairs, Drug Safety... ...functional teams and senior leadership. Roles... ...on standards, and managing issue escalation.... ...or higher in life sciences, pharmacy... ...supporting NDA/BLA/MAA submissions and post‑approval...SeniorRegulatoryFull timeRemote workFlexible hours
- ...approach to complex trial data and regulatory submission challenges. With a global... ...- rooted in strong science and decades of regulatory experience... ...in developing and marketing life-changing therapies to... ...Contribute substantially to, or manages, production of interpretive...SeniorRegulatoryRemote jobWorldwide
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