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722 Jobs in Emerson, New Jersey

Navitas Life Sciences
Regulatory Operations Senior Manager

Location Princeton, New Jersey

Full Time
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Navitas Life Sciences
Navitas Life Sciences

Regulatory Operations Senior Manager

location Princeton, New Jersey

Job Type Full Time

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Job Description

We are currently seeking a Senior Manager of Regulatory Operations. Within the role you will:

  • Develop and execute novel drug regulatory strategy
  • Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines
  • Establish sound regulatory advice/position on key development issues, and communicate same to the respective stakeholders
  • Provide a high-level review of client programs and develop strategic plans for clinical, analytical, and process development
  • Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
  • Initiate, author, and/or collaborate on SOP’s, work instructions and Work Flows for the regulatory operations function. e.g. electronic Common Technical Document (eCTD) Investigational and Marketing Applications, and post-marketing compliance maintenance submissions in the United States, Europe, and RoW
  • Author clear and concise regulatory documents (CMC authoring) with oversight of all documents for regulatory submissions and associated messaging
  • Work closely with the development team to ensure overall regulatory strategy, regulatory CMC strategy, and labeling strategy for Pharmaceutical/Biological products are aligned
  • Be the point of contact between the company and the regulatory agency – serve as the regulatory liaison
  • Help strategize a road map for EU expansion: MAA planning (Type of submissions – DCP, CP, NP, MRP, Country(ies) selection for MAA and for being CMS vs. RMS and Inputs to set up EU QPPV Office

Desirable Skills and Experience

  • 10 – 15 years’ experience working in a regulated, life science environment
  • Strong project management skills
  • Good interpersonal skills
  • Business development skills
  • Experience in defining organizational strategy, process and change management, KPIs and metrics, resource forecasting
  • Extensive knowledge of global submission standards, including but not limited to FDA, HC, EMA, ICH, eCTD and industry trends for dossier preparation (IND/CTA/NDA/MAA/NDA) and regulatory change management and operations.
  • Knowledge on RoW markets is a plus
  • Experience in medical device regulations is a plus
  • Knowledge of eCTD publishing systems, TRS toolbox, and related tools
  • Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas
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