Experience

Tillotts Pharma AG

• Switzerland
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Senior Manager Regulatory Affairs

  • Jul 2016 - Present

  Regulatory Lead driving registration of a new medicinal product in Europe (via the decentralized procedure) and other major regions including China. Key member of the product lifecycle team providing expertise and insights to shape the global commercial strategy. EU Regulatory Lead for a centralized product responsible for registration and supporting commercialization Chair of the Labelling Committee connecting a network of functional experts to manage Company Core Data Sheets. Leadership of Committee to assess and implement decisions taken. Country Manager for key strategic regions (China, Latin America, EU) responsible for regulatory strategy and implementation, in addition to managing a network of affiliates and partners. Show less



Actelion (now Janssen Pulmonary Hypertension)

• Switzerland
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Regulatory Affairs Consultant

  • Feb 2014 - Jun 2016

  Provide regulatory expertise to product filing team, to enable registration of a new medicinal product globally (and via the centralized procedure in EU) Regulatory Lead for the registration activities in Asia Pacific. Including authoring of country specific submission components from company master documents, review and approval of orphan designation applications, labels, risk management plan and ethic sensitivity assessments Regulatory responsible for clinical development activities such as creation, review and submission of clinical trial applications and associated documents (e.g. IMPD). Show less



Bayer Consumer Care AG

• Switzerland
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Senior Regulatory Manager

  • Oct 2012 - Feb 2014

  Global Regulatory Lead within the Medicated Skin Care division responsible for a product portfolio covering cosmetics, medical devices and direct to consumer medicines Accountable for global regulatory strategy, including clinical development Led internal quality, clinical and safety sub-teams for new product registrations & lifecycle activities including dossier preparation and responding to health authority queries Authored and approved variation packages including reformulations, site transfers and labelling updates to ensure compliance with current guidelines Show less



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Regulatory Consultant

  • Nov 2010 - Jul 2012

  Global Regulatory Lead for an anti-inflammatory products portfolio including providing support and strategy for on-going labeling and manufacturing projects Responsible for implementing regulatory strategy and managing operational activities for assigned regions Provided input into global regulatory strategy, including identification of gaps or risks in global strategic plan Providing input and advice to product safety and quality teams as regulatory representative on cross functional teams Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Consultant

  • Oct 2005 - Nov 2010

  Generation, review, and submission of a broad range of regulatory applications Organisation and participation in the review of UK and EU labels to ensure compliance with current legislation, company core safety information and registered particulars Maintenance of close working relationships with the Regulatory Agencies including discussion of potential safety issues, scientific advice and pre-submission meetings Generation, review, and submission of a broad range of regulatory applications Organisation and participation in the review of UK and EU labels to ensure compliance with current legislation, company core safety information and registered particulars Maintenance of close working relationships with the Regulatory Agencies including discussion of potential safety issues, scientific advice and pre-submission meetings



RANBAXY EUROPE LIMITED

• United Kingdom

• Regulatory Project Manager

  • Mar 2002 - Oct 2005

  Line management of regulatory executives including annual reviews and career planning Provided European strategy for regulatory filings to support optimal business plan Managed third parties, for both in-licensing and out-licensing of products Line management of regulatory executives including annual reviews and career planning Provided European strategy for regulatory filings to support optimal business plan Managed third parties, for both in-licensing and out-licensing of products



Generics [UK] Limited

• Regulatory Affairs Officer

  • Sep 1997 - Mar 2002

  Prepared and submitted national and MRP regulatory applications Prepared and reviewed documents for regulatory submission Prepared and submitted national and MRP regulatory applications Prepared and reviewed documents for regulatory submission