Summary
Overview
Work History
Education
Skills
Timeline
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Niamh Panesar

Niamh Panesar

Didcot,Oxfordshire

Summary

Resourceful and adaptable Director with 24 years of experience. An analytical problem-solver with talents for team building, leading and motivating, as well as excellent customer relations aptitude and relationship-building skills. Customer-oriented, with strong history of leading high-performance teams to meet or exceed objectives. Dedicated and hardworking with internal drive to deliver excellence. Proficient in using independent decision-making skills and sound judgment to positively impact company success.


Overview

24
24
years of professional experience
6
6
years of post-secondary education

Work History

Director, Regulatory Affairs CMC

Syneos Health
Farnborough, Hampshire
07.2023 - Current
  • Program lead for multifunctional teams based across India, UK and US, delivering regulatory strategies and solutions to the pharmaceutical industry.
  • Managed daily operations by overseeing financials, key performance indicators and employee performance.
  • Allocated resources to teams and projects based on need, performance and availability.
  • Established budgets based on historical, current and forecasted business data.
  • Spearheaded strategic planning and decision-making processes aligning with mission and clients interests.
  • Acted as point of contact for high-level queries and represented team at senior leadership meetings, establishing strong rapport with client to enhance business credibility.

Associate Director, Regulatory Affairs CMC

Syneos Health
Farnborough, Hampshire
01.2022 - 07.2023
  • Directed cross-functional teams, fostering collaboration and achieving project milestones.
  • Developed strong teams by skillfully recruiting, orienting and training loyal, hard-working employees,
  • Managed and motivated high-performing teams for successful KPI attainment.
  • Cultivated continuous improvement environment, problem-solving and sharing suggestions to optimise team operations.
  • Assessed project progress, leading department meetings to increase project transparency and communication.
  • Addressed customer issues with compassion and professionalism, ensuring swift, successful resolution.

Senior Manager, Regulatory Affairs CMC

Kinapse Ltd.
Wimbledon, City of London
09.2014 - 01.2022
  • Directed day-to-day work of employees and motivated teams to exceed objectives.
  • Maintained smooth-running business operations by delegating priorities to staff abilities.
  • Applied critical thinking to analyse problems, evaluate solutions and select best decisions.
  • Monitored team performance and provided constructive feedback to address challenges.
  • Conducted periodic performance reviews for direct reports.

Manager, Regulatory Affairs CMC

Kinapse Ltd.
Wimbledon, City of London
09.2012 - 07.2014
  • Managed and supervised team members, providing mentorship and guidance.
  • Navigated regulatory landscapes, maintaining legal compliance and risk mitigation.
  • Displayed energy and enthusiasm in fact-paced environment.
  • Wrote reports outlining project progress and results.

Manager, Regulatory CMC

Pfizer
Sandwich, Kent
09.2007 - 12.2011
  • Managed clinical trial submissions, query responses, change management/amendments, annual report authoring for a number of projects across different stages of development.
  • Supported drug development teams with advice on strategic technical and regulatory risks associated with project plans, working effectively in project teams to mitigate those risks.
  • Secured approval of major post approval variation for a key product in EU and US markets by supporting compilation and review of document authoring, collaborating effectively across functions to ensure on time submission
  • Led submission and query response activities activities for a JNDA filing, authoring and reviewing key documents and leading communications with colleagues globally, ensuring mutual understanding and aggressive submission target was reached.

Senior Scientist, Chemical Research & Development

Pfizer
Sandwich, Kent
09.1999 - 09.2007
  • Consistent high quality delivery of products in a Process Research and Development group supporting clinical studies to demanding timelines through excellent planning and attention to detail, flexibility and exceptional communication with partners and customers.
  • Planned, designed and executed research work and presented results to both internal and external groups.
  • Collaborated with multidisciplinary teams within Chemical Research and Development to gather input and knowledge to complete projects and identify and resolve problems.
  • Coordinated all activities associated with the scale-up and transfer of chemical processes from lab to supply chain facilities (kilo laboratory, pilot plant, global manufacturing), troubleshooting and solving and problems as they arose on scale-up. Consistently delivered process and clinical quality bulk to agreed timelines in an independent manner.

Education

Bachelor of Science - Chemistry

University Colleague Cork
Cork, Ireland
10.1993 - 07.1999

Skills

  • Project Management
  • Project Delivery
  • Leadership
  • People Management

Timeline

Director, Regulatory Affairs CMC

Syneos Health
07.2023 - Current

Associate Director, Regulatory Affairs CMC

Syneos Health
01.2022 - 07.2023

Senior Manager, Regulatory Affairs CMC

Kinapse Ltd.
09.2014 - 01.2022

Manager, Regulatory Affairs CMC

Kinapse Ltd.
09.2012 - 07.2014

Manager, Regulatory CMC

Pfizer
09.2007 - 12.2011

Senior Scientist, Chemical Research & Development

Pfizer
09.1999 - 09.2007

Bachelor of Science - Chemistry

University Colleague Cork
10.1993 - 07.1999

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Niamh Panesar