Regulatory Submissions Jobs in USA

Job DescriptionOur Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear timely and robust strategies for registration enabled by engagement with global health authorities. We work across functions and geographies to advance development programs an...

Job DescriptionThis role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations our Company policies and procedures quality standards and adverse event reporting requirements internally and...

Job DescriptionWe are seeking an experienced detail-oriented Associate Director to join the Biologics Pilot Plant (BPP) Operations team within Vaccines and Advanced Biotechnologies Process Research and Development (VAXPR&D). In this role you will lead author document and drive formal investigations...

We are seeking a detail-oriented and highly organized Nonclinical Regulatory Documentation Specialist to support quality control and submission readiness of nonclinical regulatory documents. This role will contribute to DMPK and Toxicology reporting regulatory submission modules and document lifecyc...

OverviewThe Manager Regulatory Affairs Global Development supports development and lifecycle regulatory activities across assigned products and clinical programs. This role serves as the Regulatory Affairs lead for assigned projects owning regulatory deliverables and acting as a key point of contac...

Senior Statistician IILocation:GaithersburgThe Senior Statistician II has sufficient experience working as a statistician in the pharmaceutical industry to be working independently on activities relating to design delivery and interpretation regulatorysubmissionsand/or commercialisation. This indivi...

DescriptionThe Senior Medical Writer is responsible for developing writing and managing high-quality clinical and regulatory documents that support compliance and product lifecycle needs for global standards such as EU MDR and FDA regulations. This includes planning implementing and reporting clinic...

Job OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol applicable regulations and guidelines and sponsor requirements.Essential Functions Perform site monitoring visits (selection initiatio...

OverviewElement Ann Arbor is currently seeking a highly experienced Principal Scientist Bioseparation to lead and execute advanced analytical method development characterization and validation of large molecule therapeutics across discovery development and late-stage CMC. This is an onsite laborato...

DescriptionJOB SUMMARY: The EH&S Specialist is responsible for supporting environmental health and safety compliance and risk reduction activities across the organization. This role assists with program development regulatory reporting inspections training and continuous improvement initiatives. The...

My client is a global leader in orthopedic medical devices and theyre looking for a marketing professional who wants to shape how life-changing surgical technologies reach patients around the this role your work directly influences which products get to market in which regions and how surgeons use...

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and...

We seek to move the world forward through innovative thinking.Woolpert is an award-winning global leader in architecture engineering and geospatial services. We blend design excellence with cutting-edge technology to deliver exceptional client value. Our team is passionate about their work and commi...

OverviewThis role will lead in the preparation and submission of electronic regulatory documents through the FDA EMA MHRA and Health Canada Electronic Submission Gateways (ESG) as well as prepare and file non-eCTD submissions to ensure compliance with applicable laws and regulations. The scope of th...

AstraZeneca is seeking a highly motivated and experienced Associate Principal Scientist in Viral Vector Downstream Process Development to support and expand our growing Cell Therapy and Gene Therapy portfolio. This role will play a critical leadership position in establishing robust scalable and pha...

Job DescriptionGeneral Summary: We are seeking an accomplished and strategic leader to serve as Executive Director Biotherapeutics DMPK-Bioanalysis (DMPK-BA) to guide the DMPK-BA strategy for our rapidly growing Biotherapeutics portfolio that includes protein antibody ADC and cell and genetic therap...

Job DetailsThis position is responsible for support of the administration and oversight of Health Partners Plans (HPP) Compliance Program.The Compliance Specialist will support the Compliance management team by ensuring ongoing compliance with contractual andregulatory obligations and State and Fede...

Job Description Summary#LI-Hybrid Internal Title: Associate Director/Senior Principal ScientistLocation: San Diego CAWe are seeking an enthusiastic and motivated PK Sciences project team representative to develop and implement translational or clinical pharmacology strategies to support the pursuit...

Laboratory Team Leader Microbiology and Cleaning ValidationPosition Summary: Work Schedule: Monday-Friday Days.100% based on-site in Greenville NCCatalents Greenville N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms including integrated formulation development a...

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are unique...