Regulatory Affairs Associate
The Regulatory Affairs Associate supports the preparation, submission, and maintenance of regulatory documents to ensure compliance with FDA, ICH, and other international guidelines. This role works closely with cross-functional teams to facilitate approvals and maintain ongoing regulatory compliance.
Responsibilities:
Prepare and submit regulatory filings (INDs, CTAs, amendments, annual reports)
Maintain regulatory documentation and databases
Assist with responses to health authority inquiries
Ensure compliance with GCP, FDA, and ICH guidelines
Support inspection readiness and audits
Skills & Experience:
Bachelor’s degree in life sciences or related field
Experience in regulatory affairs or clinical research preferred
Knowledge of FDA, ICH, and global regulatory requirements
Strong organizational and communication skills
EEO Employer
We are an equal opportunity employer and comply with all applicable federal, state, and local fair employment practices laws. We strictly prohibit and do not tolerate discrimination against employees, applicants, or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex, sexual orientation, gender (including gender identity and expression), marital or familial status, age, physical or mental disability, perceived disability, citizenship status, service in the uniformed services, genetic information, or any other characteristic protected under applicable federal, state, or local law. Applications from members of minority groups and women are encouraged.