The Regulatory Affairs Specialist supports the Regulatory Affairs team in ensuring company products comply with applicable regulatory requirements. This entry-level role assists with regulatory documentation, tracking submissions, and maintaining compliance records while gaining hands-on experience with regulatory processes under supervision.
Responsibilities:
+ Assist in the preparation and maintenance of regulatory submissions, registrations, and product documentation
+ Support the tracking of regulatory approvals, renewals, and change notifications
+ Maintain regulatory files, databases, and document control systems
+ Assist with responding to regulatory agency requests and internal audits under supervision
+ Monitor and summarize regulatory updates and guidance documents
+ Provide administrative and technical support to Regulatory Affairs team members
+ Collaborate with Quality, R&D, Manufacturing, and other teams to gather required documentation
+ Support post-market activities such as product changes, renewals, and reporting
+ Prepare, review, and issue documentation to support product development activities
Qualifications:
+ Bachelor of Science Degree (degree in Regulatory Affairs preferred) with no professional experience or Associates Degree in a scientific discipline with at least two years of professional experience in pharmaceutical industry
+ Understanding of cGMP documentation requirements
+ General proficiency with MS Office including word processing and database software
+ A high level of integrity and attention to detail
+ Must work efficiently with moderate supervision
+ Excellent written and verbal communication skills and strong interpersonal skills
Qualifications