With our free networking sessions, you can air common challenges of working in our sector and learn from others’ experiences. You are welcome to attend!
What we offer
- Highly interactive sessions, in a safe environment to share issues, challenges and learning
- Peer to peer advice
- Tools and tips from expert facilitator(s)
Who should attend?
Benefits
- Gain confidence to apply best practice, skills and processes in projects
- Pick up tips from those with more experience
- Build your professional network
Logistics and Costs
- 1-hour virtual session
- Free of charge (booking required)
- 8 – 16 participants
Critical Phase Project Management – Complex Regulatory Submissions
23rd April 2025, 3pm - 4pm GMT (UK time) - online meeting
Summary:
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:
- Making effective project plans for complex submissions
- Managing ownership and responsibility for key submission deliverables
- Managing extended teams and vendors across functions and within a project team governance
- Reporting progress and risks to senior leaders for effective support and decision making
- Case studies
Moderator
Preeya Beczek (BSc Hons, MSc, cGB)
With an impressive 25 years of experience in the life sciences industry, Preeya Beczek has cultivated a robust track record of leading regulatory projects that span the entire product lifecycle within various therapeutic areas. Her expertise is marked by senior roles at leading firms like PAREXEL, GSK, Pfizer, JNJ, Ipsen, and DOW Chemicals, enhancing her ability to forge strong client relationships and broaden her professional network extensively.
Preeya excels in driving teams towards achieving key regulatory and compliance milestones set by executive leadership, showcasing her capability in both strategic planning and operational excellence. Her project highlights include labelling alignment, critical phase submission management, and inspection readiness for major regulatory bodies such as EMA and MHRA. Notably, her strategies facilitated the expansion of product regulatory frameworks into new EU markets, significantly shortened lead times for secondary packaging development by 30%, and enabled early product launches to outpace competitors.
Her role as a 'critical friend' makes her a prime facilitator among clients and cross-functional teams, where she employs her subject matter expertise to elevate team performance and process efficiency. Preeya is passionate about developing effective operational models, toolkits, and processes for Regulatory Affairs (RA) teams, enhancing global collaboration, data quality, and compliance.
Preeya holds a Bachelor of Science in Chemistry and Management Studies and a Master of Science in Environmental Strategy from the University of Surrey, UK. She is also a certified Lean Six Sigma Green Belt, which underscores her commitment to continuous improvement and operational excellence.
Preeya excels in driving teams towards achieving key regulatory and compliance milestones set by executive leadership, showcasing her capability in both strategic planning and operational excellence. Her project highlights include labelling alignment, critical phase submission management, and inspection readiness for major regulatory bodies such as EMA and MHRA. Notably, her strategies facilitated the expansion of product regulatory frameworks into new EU markets, significantly shortened lead times for secondary packaging development by 30%, and enabled early product launches to outpace competitors.
Her role as a 'critical friend' makes her a prime facilitator among clients and cross-functional teams, where she employs her subject matter expertise to elevate team performance and process efficiency. Preeya is passionate about developing effective operational models, toolkits, and processes for Regulatory Affairs (RA) teams, enhancing global collaboration, data quality, and compliance.
Preeya holds a Bachelor of Science in Chemistry and Management Studies and a Master of Science in Environmental Strategy from the University of Surrey, UK. She is also a certified Lean Six Sigma Green Belt, which underscores her commitment to continuous improvement and operational excellence.