Senior Manager, Life Sciences Regulatory Submissions
EY
EY is seeking a Senior Manager for its Life Sciences Regulatory Submissions practice based in Boston. This role focuses on driving growth and establishing EY as a leader in regulatory compliance. The ideal candidate will have extensive experience in regulatory submissions and client engagement in the life sciences sector. You will lead teams in delivering high-quality client services while fostering strong relationships with stakeholders in regulatory submission scenarios. A strong background in the FDA regulatory process is essential, along with exceptional leadership and analytical skills. #J-18808-Ljbffr EY
$90k - $150k
...pioneer in industry cloud, helping life sciences companies bring therapies to patients... ..., and impactful. We are hiring a Senior Project Manager, Implementation to join our Client... ...preparing annotations for MLR/PRC regulatory submissions prior to release Coordinate cross-...SeniorRegulatoryWork at officeLocal areaWork from homeFlexible hours$67k - $93k
...global pharmaceutical and life sciences clients in the... ...are recruiting for a Senior Account Executive for... ...attitude and are flexible to manage multiple clients/... ...Facilitate the medical‑legal‑regulatory review process to... ...with clients’ online submission systems (e.g. Zinc or...SeniorRegulatoryWork at officeFlexible hours$216k - $324k
Senior Director, Manufacturing Technical Sciences Quality Assurance (Hybrid) page is loaded##... ...lifecycle management activities. This includes... ...with industry and regulatory expectations, and... ...throughout the life cycle for the... ...regulatory and product submission compliance pre and...SeniorRegulatorySummer workRemote workFlexible hours2 days per week3 days per week$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 complex... ...navigating complex Medical/Legal/Regulatory (MLR) review processes and...SeniorRegulatoryContract workWork at officeLocal areaWork from homeFlexible hours$180k - $250k
PerkinElmer is seeking a QA/RA Senior Director in New Hampshire to lead strategic quality and regulatory engagements. This role requires a strong background in life sciences quality and compliance, with significant experience in regulatory frameworks. The ideal candidate...SeniorRegulatory$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- ...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
$139k - $187k
Job Description Wave Life Sciences is a biotechnology company focused on unlocking the broad... .... Description The End User Services Senior Manager provides strategic leadership and... ...employee experience expectations, and regulatory considerations. Shape the service model...SeniorRegulatoryTemporary workSummer workLocal areaRemote workShift work- ...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/Business Development Manager (Life Sciences), US At CI&T, we help large enterprises transform the potential of AI into real business impact... ...qualification Deep understanding of the Life Sciences regulatory environment, including GxP and HIPAA...SeniorRegulatoryContract workRemote work
- The Fountain Group is seeking an experienced Project Manager (Consultant) in Boston to lead the development and regulatory submission of Class III long-term implantable medical devices. This position requires strong expertise in FDA submissions and management of cross-...SeniorRegulatoryRemote work
- 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
- ...Description About the role: The Biostatistics, Senior Manager is responsible for providing... ...data analysis of clinical trials and regulatory submissions. Statistical leadership and support... ...or in other equivalent quantitative sciences along with the following specific credentials...SeniorRegulatoryFull time
- ...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
$93.6k - $154.5k
...world. The opportunity As a Senior in Governance, Risk, and... ...the patients they serve. EY’s Life Sciences team designs and implements... ...you will be responsible for managing and delivering one or more... ...including working with Life Science regulatory statutes, GxP business...SeniorRegulatoryFull timeWork experience placementSummer holidayFlexible 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 Holdings IncSeniorRegulatoryRemote job
$180k - $250k
QA/RA Senior Director - Project Farma Location... ...the delivery of life‑changing therapies... ...high‑quality life sciences projects across... ...lead or project lead/manager, applying... ...strategic quality and regulatory engagements, including... ...investigation responses, submission support, FDA‑...SeniorRegulatoryFull time$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$160k - $200k
...Senior Pharmacovigilance Manager The Senior Pharmacovigilance (PV) Manager reports... ...the affiliate in regulatory and safety matters. Leads... ..., complete, and accurate submissions to health authorities.... ..., PharmD, MD, or PhD) in life sciences, pharmacy, medicine, or a...SeniorRegulatoryTemporary workLocal areaShift work$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 - $180k
...Overview Senior Manager of U.S. Payroll – leads accurate, compliant payroll for a multi‑state U.S. employee population, ensuring timely... ...activities. Strong working knowledge of payroll compliance and regulatory requirements. Sound judgment and strong attention to detail....SeniorRegulatoryTemporary work$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... ...disability coverage, basic life insurance, a tuition...SeniorRegulatoryTemporary workFor contractorsLocal areaFlexible hours$116.71k - $175.06k
...shape how we communicate life‑changing science to patients and healthcare... ...colleagues in medical, legal, regulatory, commercial, and... ...materials from concept to submission. Your work will enable timely... ...standards to brand teams and management as appropriate. Work with...SeniorRegulatoryTemporary workWork at office$250k - $273k
...Grounded in rigorous science and bold innovation, the... ...led by accomplished life sciences leaders. At Kiniksa... ...to): We're seeking a Senior Director, Quality... ...ensuring alignment with regulatory requirements and... ...global supplier quality management program for CMOs, CROs...SeniorRegulatoryFull timeWork at office- ...Disease. This role focuses on driving U.S. marketing initiatives, managing peer to peer engagements, and ensuring effective promotional... ...categories. Proven communication skills and knowledge of regulatory guidelines are essential for this role, providing an inclusive...SeniorRegulatory
- ...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
- The Wellington Management Company in Boston is seeking a Trust Manager responsible for overseeing trust management and operations while ensuring regulatory compliance. This senior role involves leading cross-functional initiatives, managing trust vehicles, and contributing...SeniorRegulatory
- ...seeking an Executive Director in Traditional Fund Services Product Management. In this role, you will drive product strategy and business... ...of experience in investment services, strong knowledge of regulatory requirements, and effective communication skills. We offer competitive...SeniorRegulatory
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