Director, Regulatory Affairs, Advertising and Promotions
As the Director, Regulatory Affairs, Advertising and Promotions at Chimerix, you will be integral to the development, review, risk assessment and approval of all advertising and promotional materials. Your role encompasses supporting and managing regulatory aspects of the review system, working cross functionally to drive efficient and compliant promotional material development, review and approval. You will also be the regulatory lead for all materials submitted to regulatory agencies, especially US FDA, for notification and/or review. This role requires effective leadership, communication, problem-solving, critical thinking skills and maintenance of strong interpersonal business relationships. Availability during standard business hours is expected, with occasional ad hoc responsibilities as necessary to support organizational objectives.
Key responsibilities:
- Lead Regulatory review of all promotional materials, in coordination with Medical/Legal team representatives as part of the Material Review Process.
- Assist implementation of Veeva Vault PromoMats by collaborating with key stakeholders, including IT, Medical, Legal, and Commercial teams, to ensure seamless deployment and alignment with organizational goals.
- Ensure appropriate review and approval of all promotional materials. The ideal candidate will have significant prior Ad/Promo experience, ideally including knowledge/experience of FDA requirements for programs with accelerated approval.
- Support Content Lifecycle Management: Ensure appropriate reviews of existing materials when needed, and ensure timely updates based on new data or changing requirements.
- Regulatory Compliance: Ensure Veeva Vault PromoMats generates compliant packages for eCTD submission.
- Compliance with Local Regulatory Requirements: Ensure commercial content follows local regulations.
- Stay up to date on regulatory Ad/Promo trends and changes in regulation, with primary focus on FDA, and global scope as needed.
- Ensure individual and team adherence to internal & HCP compliance, transparency rules and reporting.