Job Title: Junior Regulatory Affairs Specialist
Location: Remote – United States
Employment Type: Contract (W2 Only)
Job Summary
We are seeking a motivated Junior Regulatory Affairs Specialist to support regulatory documentation, product submissions, and compliance activities within a regulated pharmaceutical or medical device environment.
The ideal candidate will assist with regulatory submissions, document management, and cross-functional collaboration while ensuring compliance with FDA and global regulatory requirements.
Key Responsibilities
- Assist in preparing and maintaining regulatory submissions and product registrations
- Support the review and maintenance of technical documentation and regulatory files
- Ensure compliance with FDA regulations, ISO standards, and internal quality procedures
- Assist with change control, labeling, and product documentation updates
- Collaborate with Quality, R&D, Manufacturing, and Regulatory teams
- Maintain regulatory databases and document management systems
- Support audit and inspection readiness activities
- Monitor regulatory updates and assist with compliance assessments
Required Qualifications
- Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy, Biomedical Engineering, Biotechnology, or related field
- 0–2 years of Regulatory Affairs or regulated industry experience
- Basic understanding of:
- FDA Regulations
- Medical Device or Pharmaceutical Regulatory Requirements
- GMP/cGMP
- ISO 13485
- Strong communication, organizational, and documentation skills
- Ability to work independently in a remote environment