Sr.Manager Regulatory Affairs

  • location: Princeton, NJ
  • type: Permanent
  • salary: $145,000 - $150,000 per year
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job description

Sr.Manager Regulatory Affairs

job summary:
**Urgent Need for a Sr. Manager of Regulatory Affairs, person must have authored CMC Documents, have experience with the FDA and Global Regulatory Affairs, and have clinical trial Phase I-III experience**

location: Princeton, New Jersey
job type: Permanent
salary: $145,000 - 150,000 per year
work hours: 9 to 5
education: Bachelors
Responsibilities Include:

  • Provide thorough leadership across CMC and Regulatory solutions and services Bring latest thinking and insight to develop industry leading RA solutions
  • Lead working groups, forums discussions and content development to support our industry networks
  • 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 Workflows 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

  • B.S. in relevant subject area (e.g. science or industry related)

Minimum 8 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, 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 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
skills: CMC, Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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