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Regulatory Affairs Specialist

1 month ago

Hartford, Connecticut, United States Onsite Personnel LLC Full time
Job SummaryAs a Regulatory Affairs Specialist at Onsite Personnel LLC, you will play a critical role in ensuring compliance with regulatory requirements. Your primary responsibility will be to write and coordinate regulatory submissions, working closely with the Manager to prioritize tasks and maintain compliance with cGMP requirements, FDA, OSHA, EPA, and DEA guidelines.

Key Responsibilities Collaborate with cross-functional teams to procure documentation for regulatory submissions
Review technical documents for accuracy and determine acceptability for use in regulatory submissions
Create documents in accordance with eCTD specifications
Update and maintain the internal database as needed
Comply with FDA guidelines and company policies on data integrity

Requirements Bachelor's degree in Pharmacy, Chemistry, or a scientific discipline preferred
At least 1 year of experience in technical writing preferred
Minimum 3 years of experience in the pharmaceutical industry preferred
Proficient in Adobe PDF, Illustrator/InDesign, Microsoft Office, and advanced computer skills
Continuous working knowledge of applicable FDA/ICH/DEA regulations and cGMP guidelines

Onsite Personnel LLC is an Equal Opportunity Employer