Regulatory Affairs Specialist

3 weeks ago

Newtown, United States Onsite Personnel LLC Full time
Job DescriptionJob DescriptionOverview: 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:· Bachelor’s Degree in Pharmacy, Chemistry or Scientific Discipline preferred
Technical Competencies: Regulatory Associate:· At least 1 year experience with technical writing preferred· Minimum 3 years Pharma experience preferred· Proficient with Adobe PDF, Illustrator/In Design, Microsoft Office and advanced computer skills· Continuous working knowledge of applicable FDA/ICH/DEA regulations· Continuous working knowledge of applicable cGMP guidelines
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.

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