The Regulatory Affairs Associate II prepares and submits high quality routine regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. They will also support the preparation, review and archival of electronic and paper regulatory submissions ensuring compliance with FDA and other Health Authorities, company policies and procedures under the guidance of regulatory management.
• Provide detailed review of data and reports that will be incorporated into regulatory submissions to ensure scientific accuracy and clarity of presentation.
• Prepare, compile, and review regulatory submissions to ensure compliance with Health Authority regulations and guidelines, company policies/procedures.
• Manage routine submissions such as safety reports, investigator updates, and IND Annual Reports
• Assist with clinical document review such as Informed Consent Forms, Investigator Brochure, patient-facing material, and clinical labels
• Maintain regulatory archival files and databases (both electronic and paper).
• Assist with regulatory activities related to clinical study start-up, conduct, and information tracking required for GCP compliance
• Perform searches and disseminate regulatory intelligence (i.e. published approvals, guidance, and reports) relevant to Revance programs.
• Create timelines and submission plans and track deliverables to ensure on-time submissions/approvals
• Interface with Regulatory partners and internal cross-functional teams.
• 2-3 year of experience in Biopharmaceutical Regulatory Affairs. Experience with clinical regulatory affairs preferred.
• General understanding of regulatory requirements, including ICH requirements and regional requirements for US.
• Bachelor’s degree from a four year college or university.
Preferred Additional Skills (i.e., Computer):
• Proficient in MS Word, Adobe, Excel, and PowerPoint
• Must possess excellent written and verbal communication skills
• Must be detail oriented with well-developed organizational skills
• Must be able to work efficiently and independently