Senior Manager/Associate Director, RA Strategy

Company: NS Pharma, Inc.
Location: Paramus
Posted on: May 12, 2022

Job Description:

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 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 and monitors 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.
• 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.Supervisory Responsibility
  • NoneQualifications
    • 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 Privacy Always Active Sale of Personal DataSale of Personal Data Sale of Personal Data Consent Leg.Interest Select All Vendors Select All Vendors Select All Hosts Select All Information storage and access

Keywords: NS Pharma, Inc., Paterson , Senior Manager/Associate Director, RA Strategy, Executive , Paramus, New Jersey