Regulatory Affairs Coordinator
3 weeks ago
At Onsite Personnel LLC, we are seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with cGMP requirements, FDA regulations, and company policies.
Key Responsibilities:- Coordinate with cross-functional teams to procure documentation for regulatory submissions.
- Review technical documents for accuracy and determine their acceptability for use in regulatory submissions (i.e., ANDA and NDA).
- Create documents in accordance with eCTD specifications.
- Maintain the internal database as needed.
- Comply with FDA guidelines and company policies on data integrity.
- Bachelor's Degree in Pharmacy, Chemistry, or a scientific discipline preferred.
- At least 1 year of experience with technical writing is preferred.
- Minimum 3 years of pharma experience is preferred.
- Proficient in Adobe PDF, Illustrator/In Design, Microsoft Office, and advanced computer skills.
- Continuous working knowledge of applicable FDA/ICH/DEA regulations.
- Continuous working knowledge of applicable cGMP guidelines.
We offer a competitive salary range of $60,000 - $80,000 per annum, depending on experience. This position is an excellent opportunity for individuals looking to advance their careers in regulatory affairs.
About Onsite Personnel LLC:Onsite Personnel LLC is an equal opportunity employer committed to creating an inclusive work environment. We value diversity and do not discriminate based on disability, veteran status, or any other basis protected under federal, state, or local laws.
-
Regulatory Affairs Expert
2 days ago
Hartford, Connecticut, United States KVK Tech Full timeJob OverviewKVK Tech is a leading pharmaceutical company seeking an experienced Regulatory Group Leader to join our team. This role requires strong leadership and technical skills to manage regulatory submissions, ensuring compliance with cGMP requirements, FDA, OSHA, EPA, and DEA.ResponsibilitiesLead the preparation and submission of regulatory documents,...
-
Regulatory Compliance Expert
4 weeks ago
Hartford, Connecticut, United States Onsite Personnel LLC Full timeJob DescriptionOverview: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Onsite Personnel LLC.Estimated Salary:$90,000 - $110,000 per year, based on experience and qualifications.As a Regulatory Associate, your primary responsibility will be writing regulatory submissions by successfully coordinating with the Manager for...
-
Regulatory Affairs Expert Lead
3 weeks ago
Hartford, Connecticut, United States KVK Tech Full timeJob OverviewKVK Tech is a leading pharmaceutical company seeking a highly skilled Regulatory Group Leader to join our team.
-
Technical Documentation Coordinator
1 day ago
Hartford, Connecticut, United States KVK Tech Full timeAbout the RoleThe Technical Documentation Coordinator at KVK Tech will be responsible for creating and maintaining accurate and compliant technical documentation. This includes developing, writing, and reviewing technical documents such as manufacturing/packaging batch records, SOPs, and change controls. Additionally, the Technical Documentation Coordinator...
-
Business Operations Coordinator II
3 weeks ago
Hartford, Connecticut, United States HEICO Full timeAbout Heico Construction Group, LLC">We are seeking an experienced and skilled Business Operations Coordinator II to join our team. As a key member of our operations team, you will play a critical role in the planning and implementation of concrete frame and formwork projects. ">Responsibilities:">Coordinate jobsite inspections/audits of shoring,...
-
Office Operations Coordinator
2 days ago
Hartford, Connecticut, United States Capitol Region Education Council Full timeJob Description:We are seeking an experienced Office Operations Coordinator to join our team at CREF Discovery Academy. As a key member of our administrative staff, you will play a vital role in ensuring the smooth operation of our school office. This is a fantastic opportunity to work in a dynamic and fast-paced environment, utilizing your organizational...
-
Patient Safety Coordinator
3 days ago
Hartford, Connecticut, United States Charter Oak Health Center Inc Full timeAbout Our TeamWe are a dynamic and collaborative team of healthcare professionals dedicated to providing exceptional care to our patients.We are seeking a Patient Safety Coordinator who shares our commitment to quality and safety.Job ResponsibilitiesMaintain an effective infection control program that adheres to regulatory standards.Identify and investigate...
-
Administrative Coordinator
3 days ago
Hartford, Connecticut, United States Connecticut Children's Full timeJob Summary: We are seeking an experienced Administrative Coordinator to join our Neonatology team at Connecticut Children's. The successful candidate will provide administrative support to our clinicians, including scheduling appointments, managing databases, and preparing reports. This is a full-time position offering a competitive salary of $60,000 -...
-
Healthcare Coordinator RN
3 weeks ago
Hartford, Connecticut, United States Trinity Health Of New England Full timeSaint Francis Hospital, a Level 1 Trauma Center and a major teaching hospital in Connecticut, seeks a highly skilled Registered Nurse RN to join our team as a Case Manager.About the RoleThis is a full-time position working day shifts, requiring 40 hours of work per week. The ideal candidate will have at least five years of experience in acute care and/or...
-
Nurse Care Coordinator
3 weeks ago
Hartford, Connecticut, United States Trinity Health Of New England Full timeAbout the RoleWe are seeking a skilled Nurse Care Coordinator to join our team in the Emergency Department at Saint Francis Hospital.Job SummaryThe successful candidate will be responsible for coordinating patient care, assessing needs, and developing comprehensive care plans in collaboration with healthcare providers. As a key member of our...
-
DevSecOps Engineer Specialist
3 days ago
Hartford, Connecticut, United States GovCIO Full timeJob OverviewWe are seeking a highly skilled Senior DevSecOps Engineer to join our team as a Technical RPA Lead. This is an exciting opportunity for a motivated and experienced professional to lead a dynamic team of innovators in support of the Department of Veterans Affairs (VA) Robotic Process Automation (RPA) Platform Project.This position is fully remote,...
-
Technical RPA Lead
1 week ago
Hartford, Connecticut, United States GovCIO Full timeAbout the RoleWe are seeking a highly skilled Senior DevSecOps Engineer to join our team as a Technical RPA Lead. This is an exciting opportunity for a motivated and experienced professional to lead a dynamic team of innovators in support of the Department of Veterans Affairs (VA) Robotic Process Automation (RPA) Platform Project.This position is fully...
-
RPA Automation Expert
1 week ago
Hartford, Connecticut, United States GovCIO Full timeAbout the PositionWe are seeking a highly skilled Senior DevSecOps Engineer to join our team as a Technical RPA Lead. This is an exciting opportunity for a motivated and experienced professional to lead a dynamic team of innovators in support of the Department of Veterans Affairs (VA) Robotic Process Automation (RPA) Platform Project.This position is fully...
-
Clinical Oncology Care Coordinator
3 weeks ago
West Hartford, Connecticut, United States ECHN Full timeJob DescriptionWe are seeking a highly skilled and compassionate Clinical Oncology Care Coordinator to join our team at ECHN. As a key member of our interdisciplinary care team, you will play a vital role in providing high-quality patient-centered care to individuals with cancer.About the RoleThis is a full-time position that requires a Registered Nurse with...
-
Healthcare Services Coordinator
1 day ago
Hartford, Connecticut, United States Harc Inc Full timeClinical Support Professional Job DescriptionWe are seeking a dedicated and compassionate Clinical Support Professional to join our team at Harc Inc. This role involves providing medical support and care to individuals with developmental disabilities, training staff on essential skills, and ensuring compliance with regulatory requirements.Key...
-
Hartford, Connecticut, United States Amgen Full timeAbout the Role:We are seeking a highly experienced Pharmacovigilance and Medical Quality Director to lead our Safety and Medical Quality team in the UK. This role involves identifying and escalating compliance issues, participating in quality investigations, management, and remediation.About Amgen:At Amgen, we strive to be at the forefront of biotechnology,...
-
Hartford, Connecticut, United States Amgen Full timeJob Description:We are looking for an exceptional Quality Assurance Lead Observational Research to join our Safety and Medical Quality team in the UK. In this vital role, you will identify and escalate compliance issues, participate in quality investigations, management, and remediation.About Amgen:Amgen is a world-leading biotechnology company dedicated to...
-
Hartford, Connecticut, United States Amgen Full timeAs a Safety and Medical Quality Lead-Observational Research at Amgen, you will play a pivotal role in shaping the future of biotechnology and pharmaceuticals. With a strong focus on Observational research activities, this position requires a seasoned professional with a deep understanding of Good Pharmacovigilance Practice (GPvP) and Good Clinical Practice...
-
Clinical Psychiatric Director
3 days ago
Hartford, Connecticut, United States The Provider Finder Full timePrincipal Psychiatrist OpportunityEstimated Salary: $250,000 - $300,000 per annumAs a Principal Psychiatrist with The Provider Finder, you will be responsible for assessing, diagnosing, and treating patients with complex psychiatric conditions. You will also oversee the work of medical staff, coordinate treatment plans, and ensure adherence to regulatory...
-
Sanitary and Stormwater Design Expert
3 days ago
Hartford, Connecticut, United States Stantec Full timeJob DescriptionA dynamic position well-suited to an individual who is good at managing multiple tasks and deadlines and working with multi-disciplinary teams.This role may involve designing sanitary, storm, and watermain projects, overland flow / civil site plan design projects, and managing project technical tasks including completing design work,...