Sr. Regulatory Affairs Scientist

Responsibilities

• Ensure compliance with FDA Sponsor responsibilities
• Serve as a subject matter expert for regulatory strategy including identifying and mitigating risk
• Provide support to integrated project teams and working groups for submissions to and communications with the FDA
• Develop and provide input to and maintain Target Product Profiles
• Identify and mitigate regulatory risk through a project Risk Register
• Coordinate, prepare, write, review, obtain, maintain, and archive the required documents for regulatory submissions
• Represent as regulatory subject matter expert in on-site visits at the industry partner manufacturing facility
• Assist in writing and/or reviewing abstracts, papers, and publications
• Enter information in ClinicalTrials.gov for clinical studies
• Review and provide written critical regulatory feedback on acquisition documents

Requirements

• Possess a Regulatory Affairs Certification (RAC)
• US Citizen or full Green Card holder

Qualifications

Experience in regulatory affairs, including experience with FDA submission processes and regulatory strategies.

Skills

• Strong communication skills
• Ability to manage multiple projects simultaneously
• Knowledge of regulatory guidelines and standards
• Proficiency in regulatory document preparation and management

Benefits

Employee ownership culture, professional development opportunities, competitive compensation package, comprehensive benefits package including health insurance, retirement plans, and paid time off.

Pay

$85,000 - $95,000 annually

Schedule

Hybrid schedule with two days a week on-site and one day remote