Associate Director, Global Regulatory Affairs - Organon & Company : Job Details

The Associate Director will be responsible to: Develop regulatory strategy for their assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies, including but not limited to US-FDA or EU procedures (centralized, mutual recognition, decentralized)Independently manage projects within their assigned therapeutic area portfolio; functioning as the single, accountable, global point of contact or the EU-procedure regulatory expert on those projects. Lead the Global Regulatory Teams, which coordinates cross-functional regulatory support for development programs and marketed products. Independently interact with worldwide regulatory agencies and/or subsidiaries regarding global regulatory strategy/registration requirements for one or more of investigational and/or marketed drugs. Cover programs that may be complex with more than one indication, formulation, or have an external business partner. Coordinate the preparation, submission, and follow-up ...Regulatory Affairs, Director, Associate, Regulatory, Global, Product Development, Healthcare, Business Services