Regulatory Affairs Manager

This innovative pharma service provider, provides integrated product development services that help biopharmaceutical and medical device companies achieve and maintain their products on the market, no matter their size, maturity, or R&D / business model. Through their unique fusion of scientific, regulatory, and business expertise, they help clients manage risk, and maximize their product / portfolio value at every milestone and phase of development worldwide.

The Position

  • Works within a team environment or individually based on the project needs.
  • Provides guidance to project team members.
  • Works within broad project guidelines and facilitates issue and conflict resolutions.
  • Prioritizes own work load and may prioritize the work load of the project team in order to achieve the project scope and objectives.
  • Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action.
  • Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions.
  • Produces quality work that meets the expectations of PC and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met.
  • Assesses project issues and develops strategies to meet productivity, quality and project goals and objectives.
  • Manages project engagements as a project lead (small or medium).
  • Works with Project Staffing to identify and ensure appropriate resources are assigned to.
  • Actively manages performance including typical HR activities for direct reports.
  • Provides applicable guidance and support to staff in order for staff to succeed and achieve key metrics.
  • Supports development plans for staff and coordinates with senior management to ensure that staff are utilized completely and appropriately to increase their expertise.
  • Advocates for staff to senior management in order to provide opportunities to expand staff skill sets.

The Person

  • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree (MSc, PhD) Preferred; Project Management certification desirable.
  • 5+ years Regulatory experience within Pharma, Med Devices or Biopharma is highly desirable.
  • Previous line-management experience.

To learn more, apply online or contact Shane Browne on +353 1 6321865

 

 

Salary: On Application Location: Dublin City Centre