Title: Regulatory Affairs Senior Manager
Summary:
A leading, global pharmaceutical client of ours is looking to hire a Senior Manager of Regulatory Affairs at their prescription drug specific subsidiary, based out of New Jersey. This rapidly growing client has drugs spanning many different therapeutic areas from anti-invective's to psychiatry. The main function of the Manager is to provide support on writing and submitting NDAs, preparing FDA meeting requests, and working with cross-functional teams to compile and submit high quality regulatory submissions. This role will give you a great opportunity to contribute to the companies mission of producing high-quality and accessible medicines that those in need.
The Manager will be responsible for…
- Preparing and submitting new NDAs, 505(b)(2)s, INDs, ANDAs, and meeting requests to the FDA
- Thoroughly reviewing submission documentation to ensure internal consistency, adherence to relevant FDA guidelines, and to uphold regulatory excellence
- Collaborating on the establishment of project time lines, including pre-NDA and pre-ANDA activities, and ensuring milestone deadlines are achieved
- Actively participating in project team meetings, providing regulatory expertise to support complex and/or combination products
- Overseeing change management activities for existing commercial products, ensuring they are executed correctly and on schedule
The Manager should have the following qualifications:
- Bachelor's or Master's degree
- 5-8 years specifically within regulatory affairs, 7+ years within the pharmaceutical industry
- Extensive experience with regulatory activities in the US, specifically with NDA and 505(b)(2) submissions
- Strong critical and logical thinking skills with the ability to analyze problems
- Excellent verbal and written presentation and communication skills
