Critical Phase Project Management – Complex Regulatory Submissions

Critical Phase Project Management – Complex Regulatory Submissions
£ 0.00

Cross functional teams benefit from strong project management when it comes to complex regulatory submissions. Teams are often occupied with several projects and priorities within their function. Often a critical phase project manager can support cross functional teams with planning, facilitation, collaborative meetings and workshops to accelerate alignment and decision making. This can enable individuals in the team to focus on key tasks on the relevant deliverables and work to an optimised timeline. This approach can support faster submissions, approvals and medicines to patients.

We will cover these areas:

  • Working across functions for critical submissions
  • Managing ownership and responsibility for key submission deliverables
  • Managing extended teams and vendors
  • Reporting status and challenges to senior leaders for effective decision making
Preeya Beczek (BSc Hons, MSc, cGB)
Preeya has over 25 years’ experience across life sciences, chemical and the fast-moving consumer industry. She has led several Regulatory and R&D programs across the entire product lifecycle for various therapeutic areas and product platforms. Based on her extensive operational and strategic knowledge in regulatory affairs, Preeya brings relevant industry insights to help teams’ level up. Her leadership, creativity and team focused approach has resulted in increased speed and compliance.

Preeya is an excellent facilitator and a ‘critical friend’, working with clients and cross functional teams operationally and as a subject matter expert. She is passionate about creating effective teams, processes, toolkits and operating models for RA teams to enable global collaboration, data quality and compliance.

Preeya holds a Bachelor of Science degree in Chemistry and Management Studies and a Master of Science in Environmental Strategy from the University of Surrey, UK. She is also a qualified Lean Six Sigma Green Belt.
Participants will be able to:
  • Share their own challenges with like-minded people
  • Pick up some successful approaches from others, to generating better collaboration and motivating a team
  • Hear some tips from our expert moderator
  • Elect to attend further sessions
Who we welcome
  • Drug development project managers / project leaders.
  • Regulatory affairs submission / project managers
  • Pharmaceutical industry, biotech, university