Senior Manager, Life Sciences Regulatory Submissions
$165.7k - $358.7kEY
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 include leading client engagements, developing innovative solutions, and fostering a high-performing team environment. Ideal candidates will have deep regulatory knowledge and excellent interpersonal skills. Competitive base salary ranges from $165,700 to $358,700 in the New York City Metro Area. #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- ...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
$95k - $210.9k
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- EY is looking for a professional in Life Sciences Risk Consulting Services in New York. This role involves helping clients... ...biotechnology and pharmaceutical sectors identify and manage risks associated with regulatory compliance. Key responsibilities include implementing...SeniorRegulatory
$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- ...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
- 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$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$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- ...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$93.6k - $154.5k
...Philadelphia The opportunity As a Senior in Governance, Risk, and... ...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$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- ...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
- 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
$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- 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
- 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
- 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
- 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
- ...Access buildings. Position Overview The Senior Project Manager will be a core Real Estate... ...Project manager will be responsible for regulatory, lender, and investor due diligence and... ...assigned reports, applications, and submissions completed on or before deadlines Budget...SeniorRegulatoryPermanent employment
$60.8k - $93.6k
...Overview The Senior Account Executive is responsible for managing the day-to-day execution of HCP marketing deliverables. This role is highly... ..., and action-item tracking Coordinate submissions through Medical/Legal/Regulatory (MLR) review, track feedback, and route revisions...SeniorRegulatoryTemporary workFreelanceFlexible hours- IT Project Senior Analyst - Assistant Vice President Apply (opens in new... .... Requires Application Management experience to support Governance... ...and support Internal Audits and regulatory reviews, ensuring timely evidence submission, tracking of findings and closure...SeniorRegulatoryFull timeWork at office
- ...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
- ...A leading clinical research organization is seeking a Senior Project Manager to oversee and execute clinical trials. This fully remote position... ...leadership and strategic planning capabilities while ensuring compliance with regulatory standards. #J-18808-Ljbffr...SeniorRegulatoryRemote work
- ...EDETEK is seeking a senior QA specialist to ensure compliance and quality across its biometric... ...involves conducting and hosting audits, managing deviations, and collaborating with cross... ...experience, strong knowledge of GxP and regulatory requirements, and excellent...SeniorRegulatoryRemote work
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