The Regulatory Specialist will coordinate, prepare, or review regulatory submissions for domestic or international projects by preparing regulatory or compliance documentation to local and central IRBs and coordinate/submit regulatory documentation for IRB approval of clinical materials and documents. Additional activities include the review of promotional materials for compliance with applicable regulations and policies in the conduct of clinical research. The candidate must maintain a current knowledge base of existing and emerging regulations, standards, or guidance documents and update this knowledge of legal or regulatory changes to external and internal teams by interpreting regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Compile and maintain regulatory documentation databases or systems.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Communicate with regulatory agencies regarding clarification and follow-up of submissions under review
- Review product promotional materials and study documents for compliance with applicable regulations and policies.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Participate in internal or external audits.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- 2+ years in Sponsor or CRO level experience
- Bachelor’s degree or higher in related field
- Experience working in Regulatory affairs
- Strong organizational skills
- Strong computer skills
Please e-mail your resume to firstname.lastname@example.org or contact us at any time if you have questions.