Senior Manager, Life Sciences Regulatory Submissions
Ernst & Young
EY is seeking a Senior Manager for its Life Sciences Regulatory Submissions practice in Hoboken, NJ. This pivotal role involves leading the team and driving growth while establishing EY as a leader in regulatory compliance. The ideal candidate will have extensive knowledge of the life sciences market and regulatory submissions, and experience managing teams to deliver high-quality client services. Join EY to be part of diverse teams focused on shaping the future of the life sciences industry. #J-18808-Ljbffr EY
$165.7k - $358.7k
EY is seeking a dynamic Senior Manager in Life Sciences Regulatory Submissions to lead the practice and drive growth. Located in New York, you will focus on helping clients navigate regulatory compliance in the biotechnology and pharmaceutical sectors. Your key responsibilities...SeniorRegulatory- argenx SE is seeking a Senior Medical Writer to author and manage contributions for regulatory submissions, ensuring compliance with medical writing standards. The successful candidate will have a strong background in pharma or biotech, with at least 3 years of clinical...SeniorRegulatory
$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- ...an Associate Principal Consultant in R&D Advisory to lead high-impact consulting engagements across life sciences R&D domains including clinical development, regulatory affairs, and quality. The ideal candidate has over 10 years of experience in R&D consulting, proven...SeniorRegulatoryRemote job
- A leading data-focused CRO is seeking a Remote Senior Medical Writer to contribute to clinical development documents and mentor team members. Candidates should have strong writing skills, at least three years of experience in the pharmaceutical industry, and an educational...SeniorRegulatoryRemote jobFull time
$95k - $210.9k
Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have... ...Health is a leading fully-integrated life sciences services organization built to accelerate... ...; supportive and engaged line management; technical and therapeutic area training...SeniorRegulatoryContract workFlexible hours$150k - $200k
...stakes markets: healthcare and life sciences compliance technology . We are hiring a Senior Account Executive to lead... ...mission-critical challenges tied to regulatory risk, data governance, and... ...to modernize how organizations manage regulated communications and defend...SeniorRegulatoryTemporary workWork experience placementWork at office$58k - $82k
...has an immediate opening for Senior Account Executive to serve... ...specialist for our Health & Life Sciences practice. This position provides... ...direction, relationship management, measurement and analysis. Use... ...understanding of industry regulatory and promotional rules: Must...SeniorRegulatoryFixed term contractWork at officeImmediate startFlexible hours$144.4k - $189.4k
BeiGene, Ltd. seeks a Senior Manager, Statistical Programming Project Lead who will be responsible for leading project development... ...entails collaboration with clinical teams and contributing to regulatory submissions. Salary range for this position is $144,400 to $189,400...SeniorRegulatory- ...treatment center in New York is seeking a Senior Regulatory Compliance Coordinator to oversee... ...You will work closely with investigators, manage regulatory submissions, and mentor junior staff. A Bachelor’s degree in Life Science or Health Policy is required, with a Master...SeniorRegulatory
- ...Young Advisory Services Sdn Bhd is on the lookout for a Senior Manager in Risk Consulting based in New York. This critical... ...leading client engagement teams and driving regulatory submissions in the life sciences sector. The successful candidate will have over 8 years...SeniorRegulatory
- ...corrective actions. Lead country start-up strategy; maintain country intelligence; support regulatory submissions (CIRB/LIRB coordination, site documentation, CRO insurance requests). Manage site start-up activities (fast-track initiation, site calls, document collection,...SeniorRegulatory
- Merit Medical Systems Inc. is looking for a Regulatory Affairs Specialist to contribute to medical device regulatory submissions and compliance. Candidates must have at... ...Health Canada requirements. Strong project management and communication skills are essential. Join...SeniorRegulatory
- Praxis Precision Medicines, Inc. is searching for a Senior Regulatory Submissions Manager to oversee regulatory submissions to U.S. and international agencies. The role requires at least 7 years of experience in the pharmaceutical or biotech industry and strong management...SeniorRegulatoryRemote job
$134.4k - $219.2k
The Senior Manager, Global Site Start-Up Lead (SSU Lead) is responsible for driving the global... ...collection, while ensuring timely submissions and leveraging country intelligence for... ...projections and strategic plans. Support regulatory submissions as needed, including...SeniorRegulatoryLocal area$148.15k - $179.52k
Senior Manager, GRS Heme/Onc (Princeton, NJ, US) Working with BristolMyersSquibb... ..., meaningful, and life‑changing work that transforms... ...regional strategists and global regulatory teams to ensure timely, high... ...marketing application submission teams for indications at the...SeniorRegulatoryOdd jobFull timeFlexible hours- ...on rare diseases is seeking a Senior Director of Medical Writing... ...of high-quality clinical and regulatory documents across the drug lifecycle... ..., regulatory summaries) Manage external vendors and potentially... ...Ensure accurate, consistent, submission-ready documentation Support...SeniorRegulatoryRemote job
$149.3k - $195.9k
Patient Services Senior Program Manager page is loaded## Patient Services Senior Program Managerlocations... ....* Support and facilitate CRC submission of new materials and on-going review... ...Thinking & Business Agility, Industry & Regulatory (Market Access), Mentoring/ People...SeniorRegulatory- ...outstanding insurance and risk management customer service to our clients. As a Senior Client Manager, you will serve... ...meetings. Review and evaluate submissions and proposals prepared by Client... ...accounts emerging risks, cyber risk, regulatory and compliance risks,...SeniorRegulatoryContract workLocal areaFlexible hours
- ...trusted communications partner of the life sciences industry’s most respected, high performing... ...an overall PR generalist who can help manage implementation of multiple programs for... ...Understanding of healthcare and regulatory environment Highly organized, mindful...SeniorRegulatoryRemote work
$210k - $225k
...transactions, litigation/controversy issues, and regulatory matters, and for the strong... ...centers. Position Overview We are seeking a Senior Manager, Firm Recognition to join our Firm.... ...Recognition coordinates the directory submission process for all major legal...SeniorRegulatoryWork at officeLocal areaRemote workShift work$60.8k - $93.6k
...Description TheSenior Account Executiveis responsible for managing theday-to-day execution of HCP marketing deliverables.... ...contact reports, and action-item tracking Coordinate submissions through Medical/Legal/Regulatory (MLR) review, track feedback, and route revisions...SeniorRegulatoryTemporary workFreelanceFlexible hours- Position Overview Reporting to the Senior Director of Customer Success, the Senior Manager of Customer Success is... ...provided to navigate operational, regulatory, and compliance changes and challenges... ...members. Timely completion and submission of weekly/monthly reports...SeniorRegulatoryWeekend workAfternoon shift
- Senior Manager, Marketing - Interventional SpineSkip to main... ...pioneers and delivers life-changing therapies... ...year plus commitment to science and research, Ferring... ...through Legal, Medical, and Regulatory (LMR) processes.... ...creation, refinement, submission and LMR approval of marketing...SeniorRegulatoryFull timeTemporary workWork at officeLocal areaFlexible hours
$137.1k - $182.1k
...quality, fit-for-purpose clinical and regulatory documents to facilitate speed of information during development, submission, approval, and lifecycle management of products in BeiGene pipeline.... ...degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related...SeniorRegulatoryFull timeFor contractorsLocal area- ...fully remote position requires extensive experience in biopharmaceutical quality and regulatory systems, along with strategic leadership capabilities. The ideal candidate will manage end-to-end product quality, ensuring operational excellence and regulatory alignment....SeniorRegulatoryRemote job
$124.4k - $207.4k
## Senior Manager, Commercial AIA Governance & OperationsSolliciterenlocations... ...review. As the volume of submissions through the AI Innovation... ...the pharmaceutical or life sciences industry, including demonstrated... ...review and statutory or regulatory clarification, which Pfizer...SeniorRegulatoryPermanent employmentH1bLocal areaVisa sponsorshipWork visaRelocation packageFlexible hours$90k - $110k
...time opening for a Senior Account Executive... ...Consultant level at a management consultancy About... ...updates Manage submission and tracking through client regulatory and promotional... ...communications, healthcare, science) 3+ years in a... ..., consulting or life sciences) Client...SeniorRegulatoryFull timeWork at officeLocal areaImmediate startFlexible hours3 days per week- Citigroup Inc. is seeking a Senior Salesperson in New York to assist clients in raising funds and provide strategic advisory services... ..., advising teams on transactions, and ensuring compliance with regulatory standards. The ideal candidate will have over 15 years of sales...SeniorRegulatory
- Metropolitan Jewish Health System, Inc. is seeking a Managed Care Coordinator (MCC) in New York to ensure high quality, cost-effective... ...care for Medicaid and dual product members in compliance with regulatory requirements. The ideal candidate will possess excellent...SeniorRegulatory
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