Clinical Regulatory Affairs Associate III
Proclinical is currently recruiting for a Clinical Regulatory Affairs Associate III with a biopharmaceutical company located in North Chicago, IL. Successful candidate will support the Global Regulatory Leads (GRL) and US/Canada Leads in completing various reporting activities to regulatory agencies.
- Supporting annual and safety reporting (e.g., DSUR, PSUR, BLA, NDA, PMR, PADER, IND, ODD)
- Editing, review, and approval of summaries for annual reports
- Coordinating and providing input to responses to Competent Authorities or PRAC and/or CHMP safety questions, ad-hoc safety-related labeling changes, and significant safety events
- Assisting with submission documents such as financial disclosure, user fees, and Notes to reviewers
- Maintaining the Closed Loop trackers for follow up activities
- Managing SharePoint sites to ensure update to date, organized, accurate and accessible information
- Drafting, approving, and signing (on behalf of area lead): cover letters, 356h forms, 2252 forms
- Writing documents to be included in submissions (e.g., SPL)
- Entering documents into AbbVie Connect (e.g., submissions, correspondence, resolving correspondence questions, closing out records)
- Worldwide Marketing Authorization report support
- Advisory Committee planning support, including vendor interaction, consultant management and invoice approval, meeting coordination
- Trial Master verification process
- Time-permitting, assisting department with competitive intelligence tasks, including reviewing and presenting competitor labels and submission strategies
Skills and Requirements:
- Bachelor's Degree in Science (biology, chemistry etc.) required or health degree (e.g., nursing or other health related discipline) preferred.
- Understanding of FDA regulations governing INDs, NDAs, GCPs, submission processes, submission content, and specific time requirements for various submissions desired.
- A basic understanding of scientific disciplines required.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Amanda Rivera at (+1) 267-435-8555 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.