Senior Manager, Life Sciences Regulatory Submissions
EY
EY is seeking a Senior Manager to lead the Life Sciences Regulatory Submissions practice. You will drive growth and manage risk in the Regulatory Compliance sector, collaborating with clients in the life sciences industry. The ideal candidate has over 8 years of experience in Regulatory Affairs, particularly in submissions for the FDA. Strong team management and innovation in solution development are key to the role, ensuring EY's leadership in the market. #J-18808-Ljbffr
$95k - $210.9k
...Commercial LLC is seeking a Sr. Principal Regulatory Medical Writer who will be responsible for developing regulatory documents for submissions worldwide, including Clinical Study... ...Efficacy and Safety. The ideal candidate will manage multiple writing projects while...SeniorRegulatoryWorldwide- ...is seeking a Sr. Principal Medical Writer responsible for developing regulatory submission documents for clinical studies. The role requires strong medical writing expertise and the ability to manage projects with minimal oversight. The ideal candidate will have at least...SeniorRegulatoryFlexible 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
- Regeneron Pharmaceuticals, Inc is seeking an Associate Director for the Regulatory Affairs team. This role involves providing strategic oversight and leadership for regulatory milestones in therapies. The successful candidate will lead cross-functional project teams and...SeniorRegulatory
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Syneos Health is seeking a Sr. Principal Regulatory Medical Writer specializing in Oncology. This role involves developing regulatory documents and managing medical writing projects. The suitable candidate will have extensive experience in regulatory documentation, strong...SeniorRegulatoryFlexible hours$140k - $175k
Klick, based in New York, is seeking a Senior Account Director to lead key client relationships... ...experience, and a proven ability to manage financials effectively. The Senior... ...functional teams to ensure programs meet regulatory expectations and align with client objectives...SeniorRegulatory- ...consulting company, is seeking a seasoned Senior Project Manager to lead regulatory and compliance engagements for our Life Sciences clients. The ideal candidate will serve as... ...regulations, guidelines, CAPA frameworks, and submission requirements Proven track record as a...SeniorRegulatoryHome office
$140k - $175k
...Media Group, Klick Applied Sciences (including Klick Labs),... ...people and clients in life sciences. Founded in 19... ...named a Best Managed Company, Most Admired Corporate... .... Job Description The Senior Account Director leads... ...ensure flawless execution, regulatory alignment, and a...SeniorRegulatoryWork experience placement- 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 Regulatory Medical Writer - Oncology Preferred Syneos... ...a leading fully-integrated life sciences services organization built... ...Develop regulatory documents for submission to regulatory agencies... ...and corporate objectives. Manage medical writing projects, including...SeniorRegulatoryContract workFlexible hours$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... ...timelines and corporate objectives. Manage medical writing projects, including...SeniorRegulatoryContract workFlexible hours$125.3k - $349k
...IQVIA™ is The Human Data Science Company™, focused on... ...advanced analytics to help life sciences organizations... .... Role Overview The Senior Director, Sales - Large... ...Technology. Lead, coach, and manage a team of Account... ...D challenges, evolving regulatory complexity, and the...SeniorRegulatoryFull timePart timeImmediate startWorldwide$85k - $135k
...solutions partner to pharmaceutical and life science companies, we bring together... ...make a meaningful impact at BGBx. Senior Project Manager Position Overview The Senior... ...needed ~ Prepares for all legal and regulatory submissions ~ Works closely with department...SeniorRegulatoryWork at officeRemote work$93.6k - $154.5k
...The opportunity As a Senior in Governance, Risk, and Compliance... ...patients they serve. EY’s Life Sciences team designs and implements... ...you will be responsible for managing and delivering one or more processes... ...working with Life Science regulatory statutes, GxP business...SeniorRegulatoryWork experience placementSummer holidayFlexible hours- ...Senior Account Executive - Healthcare & Life Sciences In this role, you will have ownership of the full sales cycle - from identifying leads to closing... ...Life Sciences operations Experience working with regulatory and compliance requirements specific to the Healthcare...SeniorRegulatoryFull timeContract workWork at officeLocal areaRemote workHome office
$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- BeiGene, Ltd. is looking for a Senior Associate to manage U.S. regulatory submissions including INDs, NDAs, and BLAs. The role requires excellent communication, organizational skills, and a proactive approach. Experienced professionals with a scientific background and...SeniorRegulatory
$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$93.6k - $154.5k
...the patients they serve. EY’s Life Sciences team advises clients in the... ...helping clients identify, manage, and respond to risks while... ...governed by the FDA and similar regulatory bodies globally: Quality... ...Affairs (regulatory submissions, Health Registration Management...SeniorRegulatoryFull timeWork experience placementSummer holidayFlexible hours- Fosun Pharma USA Inc. is seeking a Regulatory Affairs CMC leader to steer global CMC regulatory... ...role oversees preparation, review, and submission of high-quality CMC dossiers and ensures... ..., interact with health authorities, and manage CMO and testing lab documentation to...SeniorRegulatory
- ...seeking an Associate Director of Medical Writing to oversee regulatory submissions and ensure compliance with writing standards. You will... ...medical writing within biopharmaceuticals, a Master's Degree in Life Sciences, and a passion for addressing the needs of rare disease...SeniorRegulatory
- Vir Biotechnology is seeking a Senior Regulatory Writer to support regulatory submission writing. This role requires collaboration with senior management and other leads to ensure consistent messaging and compliance. The successful candidate will have extensive experience...SeniorRegulatory
- Otsuka Pharmaceutical Co., Ltd is seeking a Senior Manager in Quality Control (Biologics) to lead QC activities across... ...role requires strong expertise in biologics and regulatory compliance, contributing to submissions like IND, BLA, and MAA. Candidates should have 8-10...SeniorRegulatoryContract workFlexible hours
$140k - $170k
...About This Role Axsome Therapeutics is seeking a Senior Manager, Biostatistics to provide statistical support for multiple... ...will contribute to Clinical Study Report (CSR) writing, and regulatory submission documents. This role is based at Axsome's HQ in New York...SeniorRegulatoryContract workFor contractorsLocal areaRemote work3 days per week$75.5k - $120.5k
...Title Project Manager Department/Discipline Project Management Company and Location Remedy... ...guidelines Prepare and upload all MLR submissions including coordination with appropriate... ...and status meetings Oversee client regulatory requirements to ensure accuracy Make proactive...SeniorRegulatoryWork at officeLocal area3 days per week- Legend Biotech, based in Somerset, New Jersey, is seeking a Senior Scientist in Toxicology. This role supports nonclinical development... ...in toxicology and pharmacology to drive the discovery and regulatory submissions of innovative therapies. With a minimum requirement of 5...SeniorRegulatoryFlexible hours
- ...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
- ...President for Contracts and Grants the Senior Contract Manager will manage and report on contract... ...administrative components for proposal submissions; performing funding research, working... ...preparing budgets, and monitoring regulatory compliance requirements. Coordinate and...SeniorRegulatoryContract workFor subcontractor
$75.5k - $120k
...Overview The Senior Project Manager is responsible for the launch planning and oversight of the project lifecycle across agency accounts... ...on budget, and error-free Advocate agency, client, and regulatory submission processes Facilitate a collaborative, steady environment...SeniorRegulatoryWork experience placementWork at office- 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
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