Senior Manager/Associate Director, RA Strategy
Company: NS Pharma, Inc.
Posted on: May 12, 2022
Department Location Reports to Status Start Date Compensation
Regulatory Affairs Paramus, NJ Director, RA Strategy Regular,
Full-Time ASAP Competitive Job SummaryThe Senior Manager/Associate
Director, Regulatory Affairs Strategy will be 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.Essential
Duties and Responsibilities (Include but not limited to the
following. Other duties may be assigned.)
- Serves as a liaison to FDA and provides strategic input with
the regional regulatory leads responsible for ex-US regulatory
- Interprets and communicates health authority correspondence
effectively and quickly to senior leadership and clinical project
- Partners with clinical project teams to assess regulatory
support needs and aligns resources to provide regulatory
- Identifies and monitors regulatory issues and reports progress
- 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
- 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.Supervisory Responsibility
- 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.Privacy Preference CenterYour PrivacyYour
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Keywords: NS Pharma, Inc., Paterson , Senior Manager/Associate Director, RA Strategy, Executive , Paramus, New Jersey
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