Senior Regulatory Affairs Specialist

Position Summary

The Senior Specialist, Regulatory Affairs will provide expertise to the organization in the development of regulatory compliance strategies and in ensuring its conformance to Health Authority requirements.

Essential Functions

• Serve as a Regulatory Affairs subject matter expert to the Regulatory Affairs team and organization.
• Approve, review, or prepare common technical documents (CTD) for technical content and compliance with regulatory requirements
• Responsible for maintaining compliance with US and International Health Authority regulations for products under development and for marketed products.
• Assist with developing and evaluating regulatory strategy
• Keep abreast of internal and external changes, trends, and developments to the regulatory environment that may have an impact on products.
• Author and review departmental SOPs, as well as other SOPs that may impact Regulatory Affairs.
• Performs other special projects and duties as requested.

Education & Experience

• Bachelor’s Degree in life sciences required with 7+ years of relevant regulatory compliance experience in pharmaceutical drug development required; or
• Master’s Degree in life sciences required with 5+ years of relevant regulatory compliance experience in pharmaceutical drug development required.
• Knowledge and experience with organizing responses to Regulatory Authority requests required
• Experience with US and International Health Authority regulatory submissions preferred

Knowledge, Skills, & Abilities

• Knowledge of FDA, ICH and other guidance documents and requirements
• Knowledge of organizing responses to Regulatory Authority requests
• Strong knowledge of Health Authority regulatory requirements/guidelines
• Strong project management and computer skills (including Microsoft office)
• Strong document management experience (hard and e-copy)
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
• Strong organizational skills, written/oral communication skills and attention to detail
• Ability to manage conflicting priorities and respond in a timely, effective manner