What are the responsibilities and job description for the Regulatory Associate position at Onsite Personnel LLC?
Job Description
Job Description
The Regulatory Affairs Associate is responsible for regulatory submissions and maintaining submission information in a proper Regulatory Affairs systems. The incumbent work cross-functional with internal departments and external resources on source documents and Regulatory related issues, ensuring those are in compliance with FDA regulations and company SOPs. The incumbent is also responsible for preparation of labeling and artwork, eCTD compilation and submission for ANDAs and NDAs registration and maintenance.
Responsibilities : Regulatory Affairs Associate :
- Interacts effectively with cross functional teams to coordinate / facilitate procurement of documentation required for regulatory submissions, ensuring that departmental timelines are met.
- Create documents in accordance with eCTD specifications.
- Prepare and submit regulatory submissions using eCTD software, publishing tool to FDA.
- Author, compile and review technical documents (CMC) for accuracy and acceptability in New Applications (i.e. ANDAs or NDAs], Amendments, Supplements, PADER, Annual Reports and other required FDA filings to ensure high-quality submissions and expeditious approvals from FDA.
- Coordinate preparation of SPL for drug products and update labelling, annual drug listing.
- Reviews and signs-off on change control documentation. Assesses changes and their impact on the business based on an understanding of product, regulatory guidelines and applicable federal laws.
- Update and maintain the internal database as needed.
- Comply with FDA guidelines / Company Policies of Data Integrity.
- Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
Technical Competencies : Regulatory Affairs Associate :
Onsite Personnel is an equal opportunity employer committed to hiring a diverse workforce in an inclusive culture environment. Onsite Personnel does not discriminate based on disability, veteran status or any other basis protected under federal, state, or local laws.