Experience

LEO Pharma UK/IE
• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Head of Regulatory Affairs UK/IE, Nordics, Australia and New Zealand

  • Mar 2020 - Present


Covance

• United States
• Research Services
• 700 & Above Employee

• Regulatory Affairs Director

  • May 2018 - Feb 2020

  Leading team of regulatory affairs experts responsible for the delivery of global regulatory affairs consultancy services to the Bio pharmaceutical Industry. Leading team of regulatory affairs experts responsible for the delivery of global regulatory affairs consultancy services to the Bio pharmaceutical Industry.



Teva Pharmaceuticals

• Israel
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director, EU RA - Generic Maintenance

  • Mar 2012 - Feb 2018

  -Provided of business analytics for RA divestment activities. liaising with legal teams, divestment consultants, buyer meetings and organising regulatory roundtable discussions -Provided RA advisory and consultation on strategic corporate pan-EU and global projects and programmes -Set-up of a highly skilled team to support RA maintenance activities on key corporate EU projects. -Effective Regulatory Affairs PV inspection readiness planning and coordination. -Established a Centralised Procedures competence and submission centre Show less



Teva Pharmaceutical Industries Ltd.

• Regulatory Affairs Manager

  • Mar 2000 - Mar 2012

  - Established off-shore EU maintenance team - Strategic corporate cross-functional pan-EU and global projects and programmes - Global co-lead on manufacturing site RA training programme. - Participation on trade association delegation (EGA) looking at revision of variations regulation. Presented on generics industry experience of regulation at 2011 EGA Annual Conference with an attendance of 250+ including industry delegates and national competent authorities - Established harmonised pan-EU maintenance processes and SOPs. - Established in-house central post approval team responsible for EU procedures only - Mergers and acquisitions - Transfer EU maintenance activities from several legacy companies to newly established central RA team - Streamlined processes - Established the corporate governance role Show less



Abbott Laboratories

• Colombia
• Personal Care Product Manufacturing
• 200 - 300 Employee

• Senior Regulatory Affairs Officer

  • 1998 - 2000

  -UK and Ireland - Regulatory maintenance support including regulatory advice, clinical trial approvals, sign-off of promotional materials -UK and Ireland - Regulatory maintenance support including regulatory advice, clinical trial approvals, sign-off of promotional materials


Merck Generics
• Regulatory Affairs Officer

  • 1995 - 1998