Job description

Overview

We are seeking a Regulatory Affairs Specialist to join our team on a contract basis, working remotely within the United States. The specialist will facilitate regulatory submissions and help maintain compliance with both FDA and global regulations pertaining to pharmaceutical, biotechnology, or medical device products.

Key Responsibilities

Assist in preparing regulatory submission documents.
Manage and maintain regulatory documentation and recordkeeping.
Review technical documentation and product labeling for compliance accuracy.
Ensure adherence to FDA and international regulatory standards.
Collaborate with various internal teams to address regulatory requirements.
Monitor changes in regulations and update compliance protocols accordingly.
Provide support during regulatory inspections and audits.

Qualifications and Skills

Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Sciences, or a related discipline.
Up to two years of experience in regulatory affairs is preferred.
Familiarity with FDA regulations and Good Manufacturing Practices (GMP) is advantageous.
Strong communication skills, both verbal and written.
Excellent organizational capabilities and attention to detail.

Additional Information

This is a contract role, fully remote within the United States. Candidates with the specified educational background and regulatory knowledge are eligible to apply. For inquiries, please contact Abhiram, Recruiter at United Consulting Hub via email.