Summary:
A global health care company, dedicated to improving people's lives through innovative solutions specialised in pharmaceuticals, medical devices, and over-the-counter products is looking to bring on an Associate Director of Regulatory Affairs Ad/Promo to join their team! The Ad/Promo team is rapidly growing, and they are looking for someone to come in and provide their expertise, based out of their New Jersey office. This role will give you an amazing opportunity to contribute to the companies mission to enrich lives by delivering better health outcomes.
The Associate Director will be responsible for…
- Reviewing Ad/Promo materials, new campaigns, and launch strategies for assigned products to ensure regulatory compliance. Ensure timely and accurate evaluation to meet deadlines and requirements
- Developing and implement regulatory strategies and solutions to ensure all ad/promo material comply with regulatory requirements and company policies
- Monitoring FDA activities, including enforcement actions and guidance documents, to assess their impact on company products
- Ensuring that promotional package inserts and important safety information are updated as necessary
The Associate Director should have the following qualifications:
- Bachelor's degree is required in Life Science or related field; Advanced degree (MS, MD, PhD, PharmD) preferred
- Minimum of 8 years of pharmaceutical experience; 4+ years of prescription product ad/promo review experience
- Working knowledge of the Rx product NDA and labeling processes
- Course training in ad/promo review
- Strong interpersonal skills, ability to work on a team, and communication skills
Benefits:
- Medical, Dental and Vision insurance
- 401(k) matching
- Tuition reimbursement
- Commuter benefits
