Senior Manager, Life Sciences Regulatory Submissions
Ernst & Young
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
$175k - $195k
...Grounded in rigorous science and bold innovation,... ...led by accomplished life sciences leaders. At... ...Patient Marketing, the Senior Manager, Marketing Operations... ...meetings to manage timely submissions and prioritization of... ...medical, legal, and regulatory review team,...SeniorRegulatoryContract workWork at officeFlexible 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$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$137k - $215.27k
...and a long-term commitment to science, its teams apply data,... ...decisions. Role Overview The Senior Manager, Biostatistics provides strategic... ...strategies and supporting regulatory interactions. Key Responsibilities... ...Contribute to regulatory submissions and responses, including...SeniorRegulatoryWorldwide$119.85k - $157.3k
...This Is What You Will Do Senior Manager, Biostatistics has sufficient experience working as a statistician in the pharmaceutical industry... ...design, delivery and interpretation, preclinical studies, regulatory submissions and/or commercialization. This individual is able to...SeniorRegulatoryHourly payTemporary workWork at officeFlexible hours- ...company leading with science to make life-changing therapeutics... ...of our clinical and regulatory development strategies... ...About the role The Senior Director, Patient... ...Pharmacy, HUB, Field Case Managers) to provide a best-in... .... All candidate submissions must be coordinated through...SeniorRegulatoryLocal area
$134.62k - $201.25k
...The Senior Manager, Quality Control (Small Molecules) will... ...product release, and regulatory compliance. This role... ..., and post-approval submissions through preparation,... ...Chemistry, Pharmaceutical Sciences, or a related... ...company provided basic life, accidental death & dismemberment...SeniorRegulatoryContract workTemporary workLocal areaFlexible hours$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- ...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 workWorldwide
- Why Join Sunrise Senior Living At Sunrise Senior Living, we believe... ...& Marketing Plans • Build and manage referral networks to generate... ...paperwork completion • Ensure regulatory compliance and smooth transitions... ...goals - at work and in your life. We also offer benefits and...SeniorRegulatoryFull timeWork at officeLocal areaShift workWeekend workAfternoon shift
$134.75k - $162.89k
...experience in clinical operations, data management, biostatistics, medical writing, and... ...of all sizes. RESPONSIBILITIES The Senior Medical Writer position requires writing... ...from statistical analyses for submission to regulatory agencies or sponsor use, comprehensive...SeniorRegulatoryFor contractorsWork experience placement$140k - $160k
As a Senior Manager at Vynamic, you will leverage your life science consulting expertise to drive transformative outcomes for clients, fostering innovation and strategic growth within the life sciences industry. You will play a pivotal role in shaping strategies, managing...SeniorFull timeFlexible hours- ...About This Role The Senior Director, Marketing, Rare Disease - Friedreich Ataxia (FA... ...will lead a team of 4-5 professionals and manage US brand strategy and tactics for the... ...Forecasting, Analytics, Omnichannel, Legal, Regulatory and HR to achieve objectives....SeniorRegulatory
- ...Accountabilities : Site Management Responsibilities... ...for study start-up and regulatory maintenance. Tasks may... ...application process; submission of proper application/... ...Collaborates with local Medical Science Liaisons (MSLs) as... ..., preferably in life science, or equivalent...SeniorRegulatoryLocal areaRemote workFlexible hoursShift work
$32 - $35 per hour
...Resources Inc.(Scientific/ Clinical/Life Sciences /Pharmaceuticals /Engineering/... ...the supervision of the Lead CRC, Senior Research Manager and Principal Investigator for assigned... .... May be responsible for IRB and regulatory submissions and maintenance of regulatory...SeniorRegulatoryContract workWork at officeShift work$80k - $200k
...industry cloud, helping life sciences companies bring therapies... ...consultant to lead MedTech Regulatory Information Management (RIM) implementations at... ...Identification) or global submission planning Interviewing... ...conversation with our group's Senior Leader. Once all...SeniorRegulatoryWork at officeLocal areaWork from homeFlexible hours$150k - $180k
...infrastructure. Description of Role The Senior Medical Writer will author and manage clinical regulatory documents in support of the... ...reports, and other regulatory submissions. Collaborate closely with... ..., medical, dental, vision, and life insurance, paid time off, and a...SeniorRegulatoryFull time$95k - $105k
...your background is in life sciences, finance, IT, sales... ...seeking an experienced Senior Supervisor to join... ...Insourcing Solutions management to maintain operational... ...and support regulatory audits... ...participate in the resume submission process, please contact...SeniorRegulatoryContract workLocal areaWorldwideFlexible hours$232k - $348k
Job Description General Summary The Senior Director, Market Enablement will lead workstreams... ...Demonstrated understanding of legal, regulatory, and compliance requirements... ...experience in marketing, sales/account management, consulting, or an equivalent combination...SeniorRegulatoryFull timeSummer workLocal area- ...Senior Managing Counsel, Privacy & Cybersecurity About the Company Multinational life sciences company focused on privacy, cybersecurity, and health data compliance. Industry... ...compliance with contractual and regulatory obligations, and managing legal risks related...SeniorRegulatory
$242k - $313k
...Senior Director, Biostatistics Beeline Medicines... ...to provide durable, life‑changing impact. Led... ...by world‑class life science investors, each day... ...statistical voice in regulatory interactions and submissions. Work Arrangement &... ...Biometrics organization. Manage and provide...SeniorRegulatoryLocal area2 days per week$162.7k - $220.2k
...Senior Portfolio Growth Manager – AWS Startups Develop strategic partnerships between innovative startups... ...corporate venture capital, regulatory bodies, and technology partners—to help... ...Preferred Qualifications PhD in Computer Science or MBA Amazon is an equal‑opportunity...SeniorRegulatoryLocal area- ...highly respected financial services organization, is seeking a Senior IT Project Manager to join their team. Responsibilities Lead complex IT... ...organizational governance standards. Ensure alignment with regulatory, compliance, and risk requirements. Contribute to continuous...SeniorRegulatory
$112.5k - $165k
## Senior Medical WriterApplylocations: Cambridge (US)time... ...the writer will develop regulatory documents for submission to global health authorities... ...applies strong project management skills and contributes to... ...(essential):* Life sciences degree, preferably MSc or...SeniorRegulatoryTemporary workWork at officeLocal areaFlexible hours- ...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...SeniorRegulatoryPrivate practiceWork at officeLocal area
- A clinical-stage biotechnology company is seeking a Medical Writer to lead the development of regulatory and clinical documents. The role requires expertise in medical writing and collaboration with various teams to ensure high-quality documentation. Candidates should...SeniorRegulatory
$123k
...change, growth, and opportunity. What You Will Do: * Manage tax compliance and advisory services for individuals... ...other staff to ensure accuracy and compliance with regulatory standards * Engage proactively with senior client stakeholders to identify tax issues, offer insights...SeniorRegulatoryHourly payWork at officeFlexible hoursNight shift$293k - $379.5k
...opportunity to provide durable, life-changing impact. Led by an... ...backed by world-class life science investors, each day Beeline... ...life fully. Job Summary: The Senior Medical Director, Clinical... ..., and clinical sections of regulatory submissions (IND, NDA/BLA, global filings...SeniorRegulatoryLocal areaFlexible hours2 days per week$139k - $209k
...where strategic thinking meets operational excellence. As a Senior Manager, Tax, you would be responsible for leading and supporting complex... ...advisors ~ Assistwith foreign corporate governance regulatory requirements and filings. ~ Develop andmaintaintax...SeniorRegulatoryFixed term contractLocal areaHome office$138k - $208k
...The Order-to-Cash (OTC) organization manages the end-to-end process that converts customer... ..., and reporting. The Senior Manager, OTC will manage the design, execution... ...ensure alignment with business models and regulatory requirements Assist with management of...SeniorRegulatoryContract workRemote work
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