Regulatory Affairs Senior Associate
New
United StatesFull-TimeSenior
Salary83,974 - 113,613 USD per year
Apply NowOpens the employer's application page
Job Details
- Experience
- At least 2 years of regulatory or pharmaceutical experience
- Required Skills
- Project CoordinationCompliance
Requirements
- Master’s degree preferred, or equivalent combination of education and regulatory/pharmaceutical industry experience.
- Bachelor’s degree with at least 2 years of regulatory or pharmaceutical experience, or equivalent alternative qualifications.
- Understanding of FDA regulatory processes, submission documentation, and regulatory compliance standards.
- Strong organizational and project coordination skills with the ability to manage multiple priorities and deadlines.
- Excellent written and verbal communication skills with strong attention to detail.
- Ability to work collaboratively within cross-functional global teams in a fast-paced environment.
- Experience with regulatory document management systems and preparation of regulatory submissions is a plus.
- Proactive mindset with strong analytical and problem-solving capabilities.
Responsibilities
- Support U.S. regulatory activities related to INDs, NDAs, BLAs, amendments, annual reports, and other regulatory submissions.
- Prepare, organize, and maintain regulatory documentation, correspondence, and product history records within regulatory management systems.
- Assist regulatory leads in developing strategic plans, conducting regulatory research, and preparing supporting materials for submissions and agency interactions.
- Coordinate collection, quality review, and submission readiness of regulatory documents and briefing packages.
- Participate in Global Regulatory Team activities, including meeting coordination, documentation, and communication support.
- Manage routine regulatory correspondence, FDA forms, and investigator-initiated study support documentation.
- Contribute to process improvement initiatives, template maintenance, compliance activities, and operational metrics tracking.
View Full Description & ApplyYou'll be redirected to the employer's site
