Senior Regulatory Affairs Specialist

Responsible for supporting all aspects of regulatory compliance, submission preparation, and product lifecycle management under the direction of the department management. This role also provides cross-functional support to ensure compliance with pharmacovigilance (drug safety) reporting requirements in accordance with FDA and global regulatory standards.

Requirements

• Compilation/review of original applications (INDs, NDAs, ANDAs), amendments, supplements, annual reports and product labeling in accordance with FDA and ICH guidelines.
• Assessment of regulatory impact of proposed changes to manufacturing facilities and processes.
• Support interactions with FDA and other regulatory agencies, including drafting responses to deficiency letters and managing agency correspondence.

Benefits

• Health Insurance
• Dental Insurance
• Vision Insurance
• 401k Matching
• Paid Time Off