Sr. Regulatory Affairs Specialist I

About This Role

This role involves an Sr. Regulatory Affairs Specialist to develop and execute company regulatory objectives by managing regulatory filings for product pre-approval and post-marketing compliance, primarily with the US FDA and Canadian Health Authorities. The role requires ensuring harmonization with worldwide regulatory requirements and contributing to process improvements.

Responsibilities

• Initiate and manage regulatory filings for company-sponsored registration trials with minimal supervision
• Independently manage timelines of assigned projects in accordance with established regulatory goals
• Write, review, coordinate, and compile submissions to US FDA and Canadian Health Authorities
• Promote corporate awareness of CMC requirements, GMP requirements, and industry trends
• Develop and recommend strategies to expedite Master File submissions and regulatory approvals
• Review internal documentation including SOPs, material specifications, and stability protocols
• Maintain regulatory SOPs and create new processes and policies as needed
• Evaluate the regulatory impact of GMP compliance and validation issues
• Independently review manufacturing changes for change control and associated regulatory risk assessments
• Develop and contribute to RA process improvements to increase efficiency and accuracy of submissions to the FDA
• Cross-train staff and provide onboarding assistance for new hires to maximize resources within the department
• Independently represent the company to customers and outside agencies including the FDA
• Participate in developmental plan meetings
• Attend scientific and/or regulatory conferences and develop and cultivate positive relationships
• Ensure quality and accuracy of documents

Requirements

• 5-8 years related regulatory affairs experience and/or training
• Proven track record of successful regulatory submissions and positive relationships with regulatory personnel
• In-depth knowledge of submission requirements and guidelines including INDs, IDEs, HDEs, NDAs, BLAs and PMAs
• Ability to correctly interpret and apply international regulations

Qualifications

• Bachelor’s degree concentrating on Biotechnology or Pharmaceutical Studies
• 5-8 years regulatory affairs experience

Skills

* Required skills

Benefits