Associate Director - Regulatory Affairs -Labeling 8/19/2016
GQR Global Markets
JOB DESCRIPTIONAPPLY Our client is a global pharmaceutical and chemical group looking for an Associate Director Labeling candidate to add to their growing team outside of Boston. The successful candidate will take responsibility for promotional activities for the introduction, launch, and early LCM of marketed drug and device products.
- Provide regulatory direction in the development and approval of compliant advertising and promotional materials, disease state education, field training materials, and external communications
- Engage with key stakeholders in the creation and execution of FDA complaint programs
- Serve as the primary point of contact with the FDA office of Prescription Drug Promotion
- Lead efforts to create, modify, and review labeling documents
- BS degree in life sciences or related scientific discipline; prefer advanced degree and/or RAC.
- 5+ years experience in Regulatory Affairs (3 in promotion and/or labeling strategy), Nonclinical Research, Clinical Research
- Experience with combination (i.e., drug/device or biologic/device), biologics or drug products and oncology is preferred
- Working knowledge of FDA and international Biologics/Drug regulations; experience with IND, CTA, BLA, NDA, MAA, eCTD, and 2253 regulatory submissions.