Global Regulatory Documentation Lead, Therapeutic Area
$224.94k - $272.58kBristol-Myers Squibb Company
Bristol-Myers Squibb is seeking a leader to establish and develop a Therapeutic Area team of scientific writers in Princeton, NJ. This person will oversee the creation of high-quality regulatory documentation while applying advanced skills in regulatory standards and documentation processes. The ideal candidate has a Masters, PharmD, PhD, or MD with a minimum of 15 years of experience in pharmaceutical regulatory documentation and will play a key role in ensuring documentation consistency and quality across teams. Compensation ranges from $224,940 to $272,579, with additional benefits including health coverage, financial well-being support, and flexible time off. #J-18808-Ljbffr
$258.68k - $313.46k
...Senior Director, Global Regulatory Strategy, Neuroscience Will be a... ...projects and the Neuroscience therapeutic area. Acts as regulatory... ...staff as Global Regulatory Lead and US Regional Regulatory... ...submission of health authority documents using internal & external resources...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$254.53k - $308.43k
...portfolio of available therapeutic area-level data sources -... ...MEG, MAP & RWE and Global Medical teams. Specifically... ...Build & Lead the RWD Innovation Center... ...eligibility alignment, and regulatory considerations... ...including harmonization and documentation standards ~...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$286.31k - $346.95k
.... Position Summary Global Program Leads at BMS are strategic-thinking... ...leader is accountable to therapeutic area, R&D, commercial and... ...therapeutic advances, and evolving regulatory, patient advocacy and... ...agreement should consult that document to determine if they are...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$207.49k - $251.43k
...Director, Global Medical Evidence Generation Lead, Oncology Working with Us Challenging... ..., Clinical Operations, Regulatory, HEOR, Access & Value)... ...across geographies and therapeutic areas. Oversee operational... ...agreement should consult that document to determine if they are...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workWork at officeRemote workFlexible hours- ...profile of Otsuka products. Leads the development and... ...leadership of the Global Medical review function... ...matters to engage with regulatory agencies on product... ...Aids and other guidance documents relevant to medical review... ...with personnel in therapeutic specialty groups at meetings...RegulatoryContract workTemporary workFlexible hours
$341.36k - $413.65k
...Vp, Global Program Lead - Cell Therapy Working with Us Challenging. Meaningful... ...multiple myeloma disease area strategy. Technical/... ...members Participates in regulatory filings (NDA, BLA filings),... ...experience in related therapeutic area Additional requirements...RegulatoryFull timeTemporary workFlexible hours$249.97k - $388.13k
...Summary: The Executive Director, Global Value Evidence Lead, is a strategic leader responsible... ...generation initiatives to support regulatory, HTA, and payer submissions, and demonstrate... ...: Experience in multiple therapeutic areas, including specialty or rare...RegulatoryTemporary workLocal areaFlexible hours- ...Corporation is seeking a Senior Quality Manager, Document Control and Training in Princeton, NJ. The successful candidate will lead the Quality Management System team, focusing... ...training processes, while collaborating with global teams. A Bachelor's degree and at least 10...
- ...Medical Affairs, will lead strategy,... ...Clinical Operations, Regulatory, HEOR, Access & Value... ...to developing the Areas of Interest (AOI),... ...geographies and therapeutic areas. Oversee... ...internal advisor to global and regional Medical... ...consult that document to determine if they...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work
- ...Hengrui Medicine (600276 SHA), a global pharmaceutical company with... ...pipeline across different therapeutic areas such as oncology, autoimmune... ...About the Role Regulatory Publishing Specialist supports... ...and submission of regulatory documents to the US FDA via ESG. The role...RegulatoryWork at office
$183.8k - $330.3k
...Institutional Pricing & Access Lead to shape pricing,... ...dynamics, regulatory requirements, and customer... ...audit support materials, documentation, and compliance-... ...strategies. Engage with global counterparts to... ...disease, or respiratory therapeutic areas. MBA, MPH, or other advanced...RegulatoryFull timeContract workSeasonal workWork at officeLocal areaWork from home$160k - $175k
...A global biopharmaceutical company in Princeton, New Jersey is seeking a Regulatory Project Manager to lead key regulatory submissions. The ideal candidate will have at least 8 years of experience in regulatory affairs, a degree in life science, and strong project management...Regulatory- ...supports the planning, execution, and documentation of clinical trials in the United... ...trials are conducted in compliance with regulatory requirements and company SOPs. The CPS... ..., rare disease, or other specialized therapeutic areas. Prior experience in a biotech or pharmaceutical...Regulatory
$150.03k - $224.25k
...Manager, Workday HRIS Lead is responsible for leading... ...modules across the global HR ecosystem. This... ...testing, deployment, documentation, and change adoption.... ...support GDPR and other regulatory requirements. Monitor... ...expertise in several Workday areas including Advanced...RegulatoryTemporary workLocal areaFlexible hours$334.86k - $405.77k
...assessment for assets in a therapeutic area by effectively managing a safety... ...aggregate safety review documents and safety sections of clinical trial documents and regulatory filings. Oversee signal evaluation... ...(high level) Global safety strategy in development...RegulatoryOverseasFlexible hours$150.03k - $224.25k
...Manager, Workday HRIS Lead is responsible for leading... ...modules across the global HR ecosystem. This... ...testing, deployment, documentation, and change adoption.... ...support GDPR and other regulatory requirements. Monitor... ...expertise in several Workday areas including Advanced...RegulatoryTemporary workWork at officeLocal areaFlexible hours$240k - $255k
...available across a wide range of therapeutic areas, contributing to the well-being of communities globally. At ANI Pharmaceuticals,... ...culture of accountability and lead a sales team to meet or exceeds... .... Collaborate with Legal, Regulatory, Compliance and other internal...RegulatoryTemporary workFlexible hoursNight shiftWeekend workAfternoon shift$209.6k - $313.38k
...Director, Global Clinical Development Otsuka... ...representatives, clinical, regulatory and scientific... ...clinical study and safety documents. Involved in... ...committees. Will help lead and support regulatory... ...across different therapeutic areas and experience in different...RegulatoryTemporary workLocal areaRemote workFlexible hoursWeekend work- ...Otsuka Pharmaceutical Companies (U.S.) in Princeton, New Jersey is seeking a Senior Manager Regulatory Operations responsible for coordinating high quality regulatory publishing deliverables. The role involves ensuring submissions are timely, correctly formatted, and...Regulatory
$340.87k - $413.05k
...personal lives. The Asset Lead/Clinical Development... ..., which is a global organization dedicated... ...a core member of the Therapeutic Area clinical development executive... ...components of regulatory filings Will contribute... ...o Health Authority Documents for Filings o And other...RegulatoryFull timeTemporary work- ...An established industry player is seeking a Regulatory CMC Specialist to join their dynamic team. In this pivotal role, you will participate... ...compounds. You will prepare and review essential regulatory documents, ensuring compliance with FDA, EMA, and ICH guidelines. Your...Regulatory
- ..., and project management. The ideal candidate will have over 8 years of experience in relevant domains, ensuring compliance with regulatory standards. Work will primarily be on-site in Princeton, New Jersey with occasional travel. A comprehensive benefits package is offered...Regulatory
- ...Description Job Description Title : Lead Associate- OTC Department : Regulatory Affairs Reports To : Team Lead... ...to the FDA Coordinate with global RA team to facilitate post... ...maintenance and archival of regulatory document files Excellent organizational...Regulatory
$109.25k - $149.5k
...SUMMARY The Lead Auditor, Quality Compliance will form part of the... ...ISO, GMP, GDP, GCP, and GLP, global policies and procedures, and corporate... ...consultancy on their specific area of expertise to the audit team... ...and procedures, and the regulatory and legislator requirements...RegulatoryTemporary workWork experience placement$100k - $145k
...join AXIS Capital - a trusted global provider of specialty lines... ...responsible for leading the strategy, execution, and... ..., exception pages) based on regulatory requirements, timing considerations... ...practices in filing strategy, documentation, and regulatory engagement...RegulatoryWork at office3 days per week- ...content for clinical documents including protocols, informed... ...study reports, and regulatory submissions.... ...investigator selection, lead study start-up training... ...Monitor competitors, track therapeutic advancements, and stay... ...the therapeutic area. Qualifications...Regulatory
$224.94k - $272.58k
...Bristol-Myers Squibb in Princeton, NJ is looking for a Senior Director for Global Scientific and Regulatory Documentation. This role involves leading a team of scientific writers to enhance regulatory documentation efficiency and drive innovative initiatives. Candidates...Regulatory$165k - $175k
...Pharma is a dynamic, fast-growing global biopharmaceutical company... ...SPs/vendors to identify areas of risk and develop strategy... ...accordance with global/local regulatory requirements and company policies... ...identifying and developing training documents (i.e., SOPs) for the targeted...RegulatoryTemporary workLocal areaFlexible hours$75k
...opportunities in the areas of Direct Care, Clinical... ..., the Program Team Lead is responsible for the... ...a positive, safe, and therapeutic environment Monitor... ...to agency policies and regulatory standards Carry a... ...of reports, logs, and documentation Assist with...RegulatoryFull timePart timeImmediate startMonday to FridayFlexible hoursWeekend workAfternoon shift$258.44k - $313.17k
...The Executive Director, Global HEOR - Cell Therapy must lead with a strong focus on building... ..., medical, and regulatory priorities. A key emphasis... ...for complex or specialty therapeutic areas (Cell Therapy experience... ...should consult that document to determine if they are...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work
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