Job Number: 9440
The Associate Director/Director, Regulatory Affairs Strategy will be responsible for developing, implementing, and leading short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their lifecycle. The candidate will manage and lead all of the submission related activities associated with the US and ex-US (with the exception of Japan) fillings for product. The candidate will also ensure timelines are appropriately managed and kept to, and issues are appropriately raised and resolved in a timely manner.
Contributes to the development of global regulatory strategies
Serves as primary liaison to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities.
Interprets and communicates health authority correspondence effectively and quickly to senior leadership and clinical project teams.
Partners with clinical project teams to assess regulatory support needs and aligns resources to provide regulatory support
Identifies, monitors and resolves regulatory issues and reports progress to management
Monitors regulatory submission activities and reviews regulatory documents prior to submission to ensure overall quality, compliance and timeliness
Leads the planning, execution and assessment of product life cycle Oversees planning and execution of major submissions and responses to regulatory authorities related to INDs, amendments, NDAs and supplements within company timelines and in accordance with regulations and guidelines
Provide creative and innovative ideas to move the Global Regulatory Affairs department forward to address current and future challenges
BS/BA in Life Sciences in a relevant field with 8 or more years of broad pharmaceutical experience, including 5 or more years of new drug regulated product strategy/submissions; or Master's Degree with 6 or more years of pharmaceutical experience and 3 or more years of related Regulatory experience, including fellowship experience
Experience interacting with the FDA and ex-US health authorities (with the exception of Japan)
Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document
Able to prioritize and work well in a fast-paced environment to multitask, problem solve, and motivate and lead others
Able to present to senior leadership clearly, succinctly, with open mindedness and willingness to defend difficult positions
Experience developing global regulatory strategies in coordination with clinical plans and marketing objectives
Experience in successfully leading teams and the ability to broadly represent GRA functions on project teams
Working knowledge of relevant drug laws, regulations and guidance's/guidelines
Strong sensitivity for a multicultural and multinational environment