Regulatory Submissions Jobs in USA

DescriptionThe Quality Engineer II supports product and process quality within regulated environments such as medical device biotech or pharmaceutical manufacturing. The role focuses on validating processes equipment analytical methods and facilities to ensure compliance with FDA and ISO regulations...

IntroductionThe DNREC Division of Air Quality monitors and regulates emissions to the air. Air monitoring is supported by the Ambient Air Monitoring Program which operates a network of monitoring stations throughout the State. This monitoring network measures pollutants for which national air qualit...

CSL Seqirus is a global leader in influenza prevention and the worlds second-largest influenza vaccine provider operating as a specialized division of CSL Limited. Headquartered in Melbourne Australia with major manufacturing hubs in Holly Springs NC and Liverpool UK the company operates the worlds...

The Amazon Web Services Healthcare and Life Sciences (HCLS) Professional Services (ProServe) team is seeking an experienced Clinical ProServe Cloud Architect (PCA) to join our team in this role youll work directly with pharmaceutical and life sciences customers including senior technology and busin...

Job DescriptionOur companys Quantitative Pharmacology and Pharmacometrics (QP2) Department is seeking a Team Leader (Executive Director) to support our rapidly expanding immunology pipeline.Immunology has been a strategic growth area for our company during the last years including an exciting late-s...

Heluna Health invites applications for one full-time position of Clinical Research Coordinator. Bridge HIV is a grant-funded research unit affiliated with the San Francisco Department of Public Health and the University of California San Francisco. Under the direction of Susan Buchbinder MD Bridge H...

Sumitomo Pharma Co. Ltd. is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America Inc.) focused on addressing patient needs in oncology urology womens health rare diseases cell & gene therapies and CNS. With several marketed products and a diverse pipeli...

About This RoleThe Biomarkers and Systems Biology group is seeking a highly motivated Principal Scientist to join a dynamic team responsible for developing and executing bioanalytical strategies across multiple therapeutic programs. This role is central to the development optimization and validation...

Sumitomo Pharma Co. Ltd. is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America Inc.) focused on addressing patient needs in oncology urology womens health rare diseases cell & gene therapies and CNS. With several marketed products and a diverse pipeli...

Principal Programmer - Clinical Data Oversight & Standards provides leadership and oversight for clinical data build programming and vendor deliverables across in-house hybrid and outsourced studies ensuring alignment with CSL standards regulatory requirements and industry best practices.The role dr...

Changing lives. Building Careers.Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us change equals opportunity. Every day our colleagues are challenging whats possible and making headway to innovate new t...

Ann & Robert H. Lurie Childrens Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence kids and t...

Sumitomo Pharma Co. Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America Inc.) Canada (Sumitomo Pharma Canada Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology urology womens health rare dise...

Job DescriptionWe are seeking an experienced and innovative Associate Principal Scientist to join the Process Analytical Technologies (PAT) team within Analytical Enabling this role you will collaborate with a cross-functional highly engaged team to advance the development pipeline and support comm...

Job DescriptionThe Pharmaceutical Analytical Sciences team has an opening for a director based in Rahway NJ. Join us and experience our culture first-hand - one of strong ethics & integrity diversified experiences exceptional science and a resounding passion for improving human health through innova...

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...

Job DescriptionJob Description:Under the direction of EHS Director the EHS Associate Director will be responsible for providing technical and regulatory support and implementation of all necessary measures and initiatives required by federal state and local regulations pertaining to environment and...

Job DescriptionThe Mixed Modalities team within Sterile Product Development is responsible for developing parenteral dosage forms (injections implants ophthalmic and inhaled products) for small molecules intermediate modalities and biologics from preclinical development through commercialization. Ou...

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...