What are the responsibilities and job description for the Regulatory Affairs Specialist position at Onsite Personnel LLC?
Job Description
Job Description
Overview : Regulatory Associate :
Primary responsibility is writing regulatory submissions by successfully coordinating with the Manager for priorities; while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, and DEA.
Key Duties & Responsibilities : Regulatory Associate :
- Interact with cross functional teams for procurement of documentation required for regulatory submissions.
- Review technical documents for accuracy and with supervision, determines acceptability for use in regulatory submissions (i.e. ANDA and NDA)
- Create documents in accordance with eCTD specifications.
- Update and maintain the internal database as needed
- Comply with FDA guidelines / Company Policies of Data Integrity
- Other duties as required or delegated
Education : Regulatory Associate :
Technical Competencies : Regulatory 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.
