Senior Regulatory Specialist

Job DescriptionJob SummaryWe are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at MSD Malaysia. The successful candidate will be responsible for managing a team of Regulatory Affairs Specialists and ensuring the smooth operation of all registration activities across the teams defined responsibilities.Key...

**Become a Key Player as a Lead CMC Regulatory Affairs Specialist** Insight Global is in search of a committed professional to join the Global Regulatory Affairs division of a leading pharmaceutical organization. **Key Responsibilities Include:** Crafting comprehensive CMC regulatory approaches Preparing a variety of regulatory CMC documents including...

Job DescriptionJob SummaryWe are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at MSD Malaysia. As a key member of our Regulatory Affairs Department, you will be responsible for managing a team of Regulatory Affairs Specialists and ensuring the smooth operation of all registration activities across the teams defined...

Associate Director, Regulatory Affairs UK The Regulatory Affairs team manages a broad portfolio of prescription medicines for the UK largely across the vaccine, oncology and infectious disease therapeutic areas.A new opportunity has arisen in the UK Regulatory Affairs Department, at the Associate Director level. The individual would manage a team of...

Associate Director, Regulatory Affairs UK The Regulatory Affairs team manages a broad portfolio of prescription medicines for the UK largely across the vaccine, oncology and infectious disease therapeutic areas.A new opportunity has arisen in the UK Regulatory Affairs Department, at the Associate Director level. The individual would manage a team of...

Key Responsibilities and Qualifications: Independently contribute to new product development teams by formulating regulatory strategies and preparing necessary documentation for both domestic and international submissions concerning IVD medical devices, emphasizing instrumentation and software/hardware, alongside experience in assay development. Proven...

Key Responsibilities and Qualifications: Independently assist core teams in the development of new products by formulating regulatory strategies and preparing necessary documentation for both domestic and international submissions related to IVD medical devices, emphasizing instrumentation and software/hardware, along with experience in assay development....

Immediate need for a talented Senior Documentation Specialist - III. This is a 15+ months contract opportunity with long-term potential and is located in Rahway, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID: 24-34389Pay Range: $40 - $45/hour. Employee benefits include, but are not limited to, health...

Immediate need for a talented Senior Documentation Specialist - III. This is a 15+ months contract opportunity with long-term potential and is located in Rahway, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID: 24-34389Pay Range: $40 - $45/hour. Employee benefits include, but are not limited to, health...

Senior Specialist, Financial Planning and Analysis. This position operates under the guidance of the Associate Director supporting the Discovery, Preclinical and Translational Medicine (DPTM) organization. The Discovery, Preclinical and Translational Financial Planning, Financial, Specialist, Senior, Planning, Support, Technology

Senior Operations Specialist - Facilities and Project ManagementThe West Point campus is a key manufacturing site for our company, focusing on vaccine production with a workforce exceeding 2000 employees.This facility is dedicated to the production of both bulk and final dosage forms for our vaccine offerings and is expanding to meet future demands.The...

HCLTech is seeking a highly skilled and self-driven Senior Appian Business Process Management Specialist to contribute to our mission of advancing the technological landscape through innovation and creativity.Position Type: Full-timeLocation: OnsiteKey Responsibilities:The ideal candidate will possess advanced proficiency in Appian BPM, demonstrating...

Position Overview:The Large Molecule Analytical Validation team within the Analytical Research & Development sector at Merck Sharp & Dohme is on the lookout for a dedicated Senior Principal Scientist. This role requires profound technical acumen in formulating strategies for critical reagents associated with large molecules. Role Responsibilities:The Senior...

Position Overview:As a Senior Tax Compliance Specialist at AA2IT, you will play a crucial role in ensuring the accuracy and timeliness of tax-related processes within our organization. This part-time position requires you to be on-site a few times a week, allowing for collaborative efforts with our team.Qualifications:Education: Bachelor’s degree...

This Engineer Senior Specialist (P 3) position will provide compliance project engineering leadership for the Rahway, NJ FL - Ex (Formulation, Laboratory & Experimentation) center, including the RY 119 Development center and the WP Sterile Liquids pi Project Engineer, Engineer, Project Management, Senior, Project, Support, Business Services

Job Summary:Merck & Company, Inc. is seeking a highly skilled Senior Project Engineer to provide compliance project engineering leadership for the company's Formulation, Laboratory & Experimentation center. The ideal candidate will have expertise in project management, engineering, and compliance, with a strong background in supporting business services.Key...

Position OverviewThe Senior Statistical Programming Scientist plays a pivotal role in the realm of Clinical Trial Analysis and Reporting. This position is responsible for overseeing the statistical programming efforts associated with multiple and/or large-scale complex late-stage drug and vaccine clinical development projects.Key ResponsibilitiesLead...

Transportation Specialist IIThe Transportation Planner Specialist will be responsible for supporting and work cross-functionally with Clinical Supply Planning, Master Planning, Clinical Operations, Country Clinical Operations, CMOs/CROs, Logistics, Security, and Trade Compliance. To support the distribution for Clinical Trial Material utilizing approved...

Transportation Specialist IIThe Transportation Planner Specialist will be responsible for supporting and work cross-functionally with Clinical Supply Planning, Master Planning, Clinical Operations, Country Clinical Operations, CMOs/CROs, Logistics, Security, and Trade Compliance. To support the distribution for Clinical Trial Material utilizing approved...

Senior Principal Scientist/Senior Director, Precision BioinformaticsMSD Malaysia is seeking a highly experienced computational biologist to lead our Companion Diagnostics (CDx) efforts in San Diego.Job Summary:We are looking for a senior leader to oversee the development of a flexible AI/ML engine for precision bioinformatics, leveraging human data to...