Senior Manager/Associate Director, RA Strategy at The Judge Group Inc. in PARAMUS, New Jersey

Job Description:

Location: Paramus, NJ

Description: Our client is currently seeking a Senior Manager/Associate Director, RA Strategy
Responsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle. The candidate will manage and lead submission related activities associated with the US and ex-US 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.


This job will have the following responsibilities:

• Serves as a 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.


• Monitors regulatory submission activities and reviews regulatory documents prior to submission to ensure overall quality, compliance and timeliness. Assists in the planning, execution and assessment of product life cycle.


• Assists in 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.

Qualifications & Requirements:

• 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 multi-task, problem solve, and motivate and lead others.


• Able to present to senior leadership clearly, succinctly, with open-mindedness and willingness to defend difficult positions.


• Strong sensitivity for a multicultural and multinational environment.


• Education and/or Experience BS/BA in Life Sciences in a relevant field with 5 or more years of broad pharmaceutical experience, including 3 or more years of new drug regulated product strategy/submissions; or Master's Degree with 4 or more years of pharmaceutical experience and 2 or more years of related Regulatory experience. Working knowledge of relevant drug laws, regulations and guidance's/guidelines.


• Partners with clinical project teams to assess regulatory support needs and aligns resources to provide regulatory support. Identifies and monitors regulatory issues and reports progress to management.

Contact: lsmith01@judge.com


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