Experience

Biogen
• South Africa
• Wellness and Fitness Services
• 1 - 100 Employee
• Senior Manager Regulatory Affairs

  • Mar 2021 - Present


CLINUVEL (UK) LIMITED

• United Kingdom
• Biotechnology Research
• 1 - 100 Employee

• Regulatory Affairs Manager Europe

  • Sep 2019 - Oct 2020

  - Managed drug registration activities for centralised product - Managed drug registration in ROW - Clinical trials activities - Managed price/reimbursement dossier - Managed drug registration activities for centralised product - Managed drug registration in ROW - Clinical trials activities - Managed price/reimbursement dossier



Pfizer

• Events Services
• 1 - 100 Employee

• Regulatory Affairs Manager

  • Jul 2018 - Sep 2019

  Worldwide Safety and Regulatory Innovative - Europe and International -Managed Temporary Authorisation for Use (ATU)/ Temporary Recommendation for Use (RTU) for oncology products: response to questions, discussions and negotiation with the Agency - Managed launch activities for new oncology products - Clinical trial activities: manage initial submissions and maintenance with substantial amendment - Managed oncology products portfolio: drug registration activities for centralised procedure, artworks review, price/reimbursement dossier review - Direct report management Show less



Gilead Sciences

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Regulatory Affairs Associate

  • Aug 2014 - Jun 2018

  Senior Regulatory Affairs Associate, HIV/Cardiovascular/Oncology- Marketing authorisation application through centralised procedure: Pre-MAA and Post-authorisation activities.- Clinical trials activities: managed and submitted initial clinical trial applications in the EU in collaboration with cross-functional team, Gilead Regulatory Affiliates and CRO.- Optimisation of regulatory process: reviewed and updated SOP.

• Senior Regulatory Affairs Associate, HIV

  • Oct 2013 - Aug 2014

  - Drug registration activities for centralised products- Clinical trials submissions- Advertising control for promotional material - Reviewed training material for sales rep- Price/Reimbursement dossiers review



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs, HIV, Immunology, Anesthesia

  • Jan 2012 - Nov 2013

  - Drug registration activities for national, centralized products - Advertising control for promotional material - Reviewed training material for sales rep - Drug registration activities for national, centralized products - Advertising control for promotional material - Reviewed training material for sales rep



Daiichi Sankyo, Inc.

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs, Cardiovascular

  • Nov 2010 - Nov 2011

  - Post-authorisation activities for national products - Advertising control for promotional material - Regulatory review of company events ensuring compliance with French anticorruption law (DMOS) - Post-authorisation activities for national products - Advertising control for promotional material - Regulatory review of company events ensuring compliance with French anticorruption law (DMOS)



Bristol-Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs, Cardiovascular, Oncology/Infectiology

  • May 2010 - Nov 2010

  - Drug registration activities for national products - Clinical trials submissions - Advertising control for promotional material - Drug registration activities for national products - Clinical trials submissions - Advertising control for promotional material



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs, Cardiovascular, Neuroscience

  • Sep 2009 - May 2010

  - Involved in the creation and update of the CCDS - Presented of CCDS to Labelling Review Committee - Prepared labelling document for the paediatric work sharing (EU- article 45) / PSUR work sharing - Tracked the implementation of the CCDS across regions - Involved in the creation and update of the CCDS - Presented of CCDS to Labelling Review Committee - Prepared labelling document for the paediatric work sharing (EU- article 45) / PSUR work sharing - Tracked the implementation of the CCDS across regions