Senior Director, Regulatory Affaris (Vaccines)

Our client is a global organization specializing in Vaccine Development and is seeking a Senior Director of Regulatory Affairs to provide high level Regulatory Affairs advice, identify Regulatory requirements and set regulatory strategy for international development.

In this role, the individual will be responsible for obtaining Regulatory approvals, ensuring that the Regulatory Affairs department is compliant with federal, state and international laws, handling the oversight of all aspects of Regulatory Affairs internationally for multiple projects, developing and implementing Global Regulatory Affairs Strategy, giving strategic advice to Senior Management on International Regulatory Requirements, and overseeing a network of Regulatory Affairs Professionals. This individual will also deliver presentations to Regulatory Authorities and create documents regarding Regulatory Strategy for Senior Management.

Our client would like the following credentials/experiencePhD, MD or MPH degree together with extensive experience in Vaccine Development. At least five years of experience in Regulatory Affairs with bio-pharmaceutical/pharmaceutical products and at least three years of experience in another aspect of bio-pharmaceutical/pharmaceutical product development (Clinical, Pre-Clinical, or CMC Development). Thorough knowledge of Vaccine Development with Clinical, Regulatory Affairs experience along with experience in CMC and/or Pharmacology, Toxicology and Biostatistical Analysis. Experience in gathering Regulatory Intelligence and developing product approval strategies. Experience in Managing Regulatory Affairs professionals. Ability and experience interacting with Regulatory Authorities. Prior experience managing Regulatory Submissions with the ability to successfully manage projects. Thorough understanding of relevant vaccine development regulations and guidelines. Outstanding interpersonal skills. Experience working with Computer and Standard Software Programs.

In return for your expertise, our client offers an outstanding salary plus bonus,  very thorough and excellent benefits package and also offers a very diverse and ethical workplace with extremely dedicated and talented individuals. Interested/Qualified candidates, please send your complete CV/Resume in MS Word format to Caryn Reiman, caryn@ultimatesolutions.com or call (201) 909-3717 for more information. Replies shall be held in the strictest of confidence.