Role Description. This is a full-time on-site role for a Regulatory Affairs Associate located in Bridgeport, CT. The Regulatory Affairs Associate will collaborate with teams to prepare, review, and manage regulatory documentation, ensure compliance with regulatory requirements, and support regulatory submissions. They will stay informed on industry regulations and guidelines while maintaining effective communication with regulatory authorities as...
Role Description. This is a full-time on-site role for a Regulatory Affairs Associate located in Bridgeport, CT. The Regulatory Affairs Associate will collaborate with teams to prepare, review, and manage regulatory documentation, ensure compliance with regulatory requirements, and support regulatory submissions. They will stay informed on industry regulations and guidelines while maintaining effective communication with regulatory authorities as...
Location. Dallas, NC. Schedule. Full-Time, On-Site. Benefits. Full benefits package, including. company-paid, high-quality medical coverage. for employees and their families. Essential Functions. Track, monitor, and communicate current, proposed, and new regulatory changes impacting the business. Independently research regulatory information in alignment with US FDA, USDA, and Canadian and Mexican regulations. Prepare timely and accurate response...
Location. Dallas, NC. Schedule. Full-Time, On-Site. Benefits. Full benefits package, including. company-paid, high-quality medical coverage. for employees and their families. Essential Functions. Track, monitor, and communicate current, proposed, and new regulatory changes impacting the business. Independently research regulatory information in alignment with US FDA, USDA, and Canadian and Mexican regulations. Prepare timely and accurate response...
Lensa is a career site that helps job seekers find great jobs in the US. We are not a staffing firm or agency. Lensa does not hire directly for these jobs, but promotes jobs on LinkedIn on behalf of its direct clients, recruitment ad agencies, and marketing partners. Lensa partners with DirectEmployers to promote this job for BD (Becton, Dickinson and Company). Clicking "Apply Now" or "Read more" on Lensa redirects you to the job board/employer s...
Lensa is a career site that helps job seekers find great jobs in the US. We are not a staffing firm or agency. Lensa does not hire directly for these jobs, but promotes jobs on LinkedIn on behalf of its direct clients, recruitment ad agencies, and marketing partners. Lensa partners with DirectEmployers to promote this job for Actalent. Clicking "Apply Now" or "Read more" on Lensa redirects you to the job board/employer site. Any information colle...
Job Description. The Regulatory Affairs Associate supports the Quality Assurance & Regulatory Affairs Director in ensuring compliance with all regulatory requirements in the USA, Canada, and Mexico. This includes regulations related to colors and plant-based ingredients used in food & beverages and pet food. The position reports to the Quality Assurance & Regulatory Affairs Director and is based in Dallas, NC. Essential Functions. . 1. Tracks, mo...
Responsibilities. Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Responsible for managing and compiling CMC sections of marketed product variations. Partner with RA CMC Project Leads and develop module 3 content and projec...
Advancing Care Through Innovation. Come Join Panoramic's Science Divison. Position is remote and Monday - Friday. 8am-5pm. To learn more about Panoramic Science visit: https://panoramichealth.com/clinical-research/. The Regulatory Affairs Associate, in concert with the Regulatory Affairs Lead, is accountable for achieving successful delivery of clinical trial activities across a multi-site clinical research network by meeting regulatory and quali...
Responsibilities. Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Responsible for managing and compiling CMC sections of marketed product variations. Partner with RA CMC Project Leads and develop module 3 content and projec...
Primary responsibility is to compile, review, and submit various regulatory filings. o *IND* (Investigational New Drug). o *NDA/ANDA/BLA* (New Drug Application/Abbreviated New Drug Application/Biologics License Application). o *DMF* (Drug Master File). o Compile CTD/eCTD Modules. o Ensure submissions follow *country-specific regulatory guidelines* (FDA, EMA, MHRA, WHO, ICH). o Monitor and interpret *changes in global regulations*, guidance docume...
