Regulatory Operations Manager

Job Description

  • 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 high level review of client programs and develop strategic plans for clinical, analytical, and process development
  • Insure 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 United States, Europe and RoW
  • Ability to author clear and concise regulatory documents (CMC authoring) with oversight of all documents for regulatory submissions and associated messaging
  • Work closely with development team to insure overall regulatory strategy, regulatory CMC strategy, 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
  • To 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 to 15 years’ experience working in a regulated, life science environment with strong project management interpersonal skills
  • Experienced in defining Organizational Strategy, Process and Change Management, KPIs and Metrics, Project Management, and Resource Forecasting
  • Extensive knowledge of Global submission standards (FDA, HC, EMA, ICH eCTD etc.), and industry trends for dossier preparation (i.e. IND/CTA/NDA/MAA/NDA) and Regulatory change management and operations. Knowledge on ROW markets is a plus
  • Experience in Medical device regulations is desirable
  • Experience in CMC and Oncology
  • 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

Princeton, NJ, USA

Degree in Life Sciences or Pharmacy

Manager

Regulatory Affairs

Full Time

12 Jan 2021