Job Title: Regulatory Affairs Manager – Fully Remote
Working Hours: 9-5 EST
Location – Bridgewater NJ
Duration: 6 Months with possible extension
Job Duties :
• Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials.
• Work directly with Commercial teams from concept through review and approval, up to and including OPDP/APLB submission.
• Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials
• Work collaboratively with Compliance and Legal to ensure that materials approved by RC are used within the intended guidelines.
• Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives.
• Work collaboratively with medical and scientific personnel on the development and review of materials related to advertising and promotion.
• Participate in training of sales and marketing personnel on promotional, labeling and advertising regulations.
• Serve as FDA liaison for matters related to the advertising and promotion of assigned products
Years of Experience: 6 plus years.