Regulatory Documents Jobs in USA

AECOM is seeking a Regulatory Permit Compliance Specialist - Environmental for one of our offices in Sacramento CA.or Fresno CA. This opportunity can be remote but within the state of California. JOB SUMMARYThis role conducts environmental compliance audits in active construction areas including rev...

The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies.Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially di...

Position Details: Our client a world-leading Pharmaceutical Company in San Diego CA is currently looking for an Quality & Regulatory Affairs Lead to join their expanding team. Job Title: Quality & Regulatory Affairs Lead / Pharma Manufacturing / Hybrid Work Duration: 15 months contract extendable...

We are seeking a Medical Director. This position will report to the Senior Medical Director of Pharmacovigilance and will be located in the Waltham office.The Medical Director is responsible for global pharmacovigilance (PV) for marketed and/or investigational products including review and analysis...

We are seeking a highly motivated Principal Research Scientist I to join the Purification Development group within Biologics Drug Substance Development organization.  Our group is responsible for the end-to-end development from first in human process development to late-stage process optimization pr...

Join AstraZeneca a global science-led biopharmaceutical company and make a more meaningful impact on patients lives around the globe. We are seeking a Senior Medical Director in Immunology Cell Therapy to craft and deliver our Immunology Cell Therapy pipeline and lead innovative clinical stage cell...

DescriptionThis entry-level role ensures adherence to institutional SOPs and applicable regulations while developing foundational expertise in human subject protections and Good Clinical Practice (GCP).This position is time limited. This position requires a level II background check.Responsibilities...

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionJoin Us as a Clinical Trial Coordinator Make an Impact at the Forefront of InnovationWe have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 cou...

Position: Quality Control Medical Writing Location: Hybrid in San Francisco CA (4-5 days in office Mon-Sat) Duration: Fulltime Year of Experience - 3 Scope of Role Helping design AI systems that write regulatory documents. Deconstructing authoring/review/QC heuristics for engineers. Evaluatin...

We are seeking a Senior Scientist I with experimental and data science skills to join our peptide hit generation this role you will:Leverage our innovative peptide microarray platform to accelerate hit identification and maturation from peptide mRNA and phage display campaigns involving analysis of...

Synterex Inc. is a global consortium of highly experienced clinical development professionals specializing in medical writing submission publishing and clinical science and operations support. Synterex offers remote or on-site services with a focus on providing clear concise accurate and fully compl...

The Associate Director Statistics provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. Specific areas of work may include clinical trials patient safety and global medical affairs. The Associate Director works in partnership with expert...

The Associate Director Statistics provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. Specific areas of work may include clinical trials patient safety and global medical affairs. The Associate Director works in partnership with expert...

The Associate Director Statistics provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. Specific areas of work may include clinical trials patient safety and global medical affairs. The Associate Director works in partnership with expert...

The Associate Director Statistics provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. Specific areas of work may include clinical trials patient safety and global medical affairs. The Associate Director works in partnership with expert...

Overview:Job Description Summary:Develops onboards coordinates and manages clinical trial study and research objectives. Meets requirements follows regulatory guidelines and observes standard operating procedures. Coordinates and executes activities with ongoing study development and process improve...

The Role:We are seeking to expand our Technical Operations group by recruiting a highly experienced and collaborative Associate Director to serve as an Early Stage CMC Program Lead. This role is responsible for end-to-end Chemistry Manufacturing and Controls (CMC) program oversight for early-stage b...

Description:The target lipid nanoparticle (tLNP) process development team is seeking a highly motivated talented and innovative scientist to develop manufacturing processes for tLNP from purified mRNA into purified tLNP bulk drug product. The successful candidate will help advance understanding unit...

Job DescriptionTheDepartment of Neurological Surgeryhas an outstanding opportunity for aResearch Coordinator 1to join their team.DUTIES AND RESPONSIBILITIES Research Coordination & Data Management 60% Identify and screen eligible patients for retrospective clinical research studies involving brain...

The Strategic Medical Writing Operations Team is dedicated to delivering high-quality scientificallyaccurate and strategically aligned clinical and regulatory documentation that supports AbbVies mission to transform the standard of care. Our team serves as a critical link between research developmen...