Junto HLS is working exclusively with our client on a Manager, Regulatory Affairs Advertising and Promotion position for a top pharmaceutical company located in the Greater Chicago Area.
- Execute regulatory activities and provide regulatory support on projects in accordance with applicable regulations and guidelines.
- Ensure regulatory compliance of promotional materials generated for assigned compounds.
- Proactively identify regulatory issues, offer creative solutions and strategies, including risk mitigation strategies.
- Plan, execute and manage regulatory OPDP submissions for assigned compounds.
- Provide regulatory support in FDA meeting preparation and interact with the reviewing staff at FDA Office of Prescription Drug Promotion (OPDP). Assist and attend FDA meeting, lead with oversight.
Select Education, Experience, Knowledge and Skills:
- BS/BSc or BA accepted, PharmD preferred.
- 5 years industry inclusive of > 3 years regulatory or related experience. Less experience may be acceptable with PharmD degree.
- Experience in reviewing, authoring, or managing components of regulatory submissions or pomotion and advertising materials or related activities.
- Knowledge of FDA regulations.
- Understanding of scientific principles and regulatory/quality systems relevant to drug development.
- Experience in reviewing, authoring, or managing components of regulatory submissions or promotion and advertising materials or related activities.
- Able to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
- Greater Chicago, IL
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to Michelle@juntoHLS.com.