Regulatory Affairs Project Manager

Location: Somerville, New Jersey Salary: competitive
Sector: Pharma & Biotech, Medical Devices, Regulatory Affairs, Regulatory Affairs (RA) Type: Contract

I am partnering with a leading Medical Device organization in Somerville, NJ to secure a Regulatory Affairs Project Manager on a 2 Year Contract to act as the facility upgrade lead and provide CMC support of day-to-day Regulatory Affairs operations.

This pays $50-$55 an hour, including expenses so this is best suited to local candidates.

Key Responsibilities:

  • Manage activities with colleagues, and contingent workers for facility expansion and for the post approval CMC change management of the licensed biologics and 510(k) products for product life cycle.
  • Work independently and serve as the point of accountability for CMC project level and product Regulatory strategies and surveillance across the full product lifecycle.
  • Responsible for drafting and compiling the content and coordination of submissions, supplements and surveillance submissions while managing colleague and contingent employees to the deliverables set by the Project.
  • Provide directional and creative solutions in compliance with the parameters of the requirements for Biological License Applications and CBER 510(k) products.
  • Defines, develops and communicates strategy for assuring projects in work plan deliver the strategic objectives. Facility upgrade strategies can encompass multi-year (2 year +) activity.
  • Lead complex regulatory negotiations for collaborative site operations.
  • Establishes submission-critical components, and manages the delivery of the submission.
  • Work with Project Leads to undertake specific upgrade activity as appropriate to the project. This might include: participating in productions that use the technology, assisting in building strategy for presentations and/or meeting with companies externally.
  • Communicates complex concepts and influences diverse groups of stakeholders across and create an environment that is receptive and enables the upgrade of specific technologies
  • Captures and monitors the impact of government regulations and other stakeholders.
  • Deliver submissions, pre-submission, prior approval inspections readiness and post commitments.

Experience Required:

  • 5-8 years of experience in Regulatory Affairs in Medical Device, IVD and/or Biologics
  • Experienced in CMC (Chemistry, Manufacturing Controls) filings/submissions for Biological License Applications and CBER 510(k) products

If this aligns with your experience and interests, apply now!

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