Experience

Douglas Pharmaceuticals

• New Zealand
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Senior Regulatory Affairs Associate

  • Mar 2019 - Present

• Regulatory Affairs Associate

  • Apr 2017 - Present



Medley Pharma Ltd

• Liverpool, United Kingdom

• Quality and Regulatory Executive

  • Jan 2015 - Jun 2016



Thompson and Capper Ltd

• Regulatory Affairs Specialist

  • Dec 2013 - Jun 2014

  Duties included:  Compiling Technical dossiers for product registrations for customers.  Submit Regulatory documents including license variations to the Regulatory authorities.  Liaise closely with customers and the Regulatory body to progress projects. Deputy Pharmacovigilance Qualified Person.  Provide Regulatory and Technical advice to Customers and the Sales team.  Help to ensure raw materials purchased by the company comply with relevant legislation, working closely with purchasing and raw materials suppliers.  Perform Product Quality Reviews and generate Periodic Safety Update Reports for licensed products.  To work closely with the new product development team and Quality departments to ensure all products comply fully with the contract agreed with the Customer and comply with all regulatory requirements.  Internal auditing to ISO 9001:2008. Show less

• Quality Control Supervisor

  • Jun 2011 - Dec 2013

  Duties included: Supervision and prioritisation of laboratory work and deputising for the QC manager. Review and release of raw materials and finished products according to specifications. Preparing stability reports, out of specification reports, non-conforming material reports and product quality reviews. Managing expired raw materials and the sample evaluation system for the approval of raw materials. Analysis of raw materials and finished products. Analysis and release of stability samples. Creating specifications and test methods. Assisting in the training of other members of staff. Show less

• Regulatory Affairs Manager

  • Jun 2010 - Jun 2011

  Duties included: Helping to prepare dossiers and collating technical information for THRs. Maintenance of the company’s traditional herbal registrations. Providing technical information to both internal departments and customers. Maintaining the pharmacovigilance system and collating adverse event data. Collating customer information files as required. Generating validation protocols and reports. Performing PQRs for licensed products and customers. Ensuring raw materials purchased by the company comply with relevant legislation. Managing Pest Control contract for the site Show less

• Quality Control Technican

  • Aug 2007 - Jun 2010

  Duties included: Validation and calibration of instruments and machines for testing of raw materials and finished products. Chemical and physical testing of raw materials and finished products according to specifications.  HPLC analysis of a range of vitamins in raw materials and finished products. Liaising with suppliers to obtain documents e.g. specifications and certificates of analysis. Working with the purchasing department to evaluate and test possible new materials for use in new or existing products. General cleaning of equipment and machines. Keeping the lab tidy and presentable for audits and/or viewing from potential customers. Show less



The Co-operative Bank plc

• United Kingdom
• Financial Services
• 700 & Above Employee

• Data Processor

  • Jul 2005 - Jan 2006

  Duties included:  processing confidential data into the computer system  sorting and distributing the post to the correct departments  filing/faxing/photocopying  letter writing  answering telephone calls Duties included:  processing confidential data into the computer system  sorting and distributing the post to the correct departments  filing/faxing/photocopying  letter writing  answering telephone calls



McDonald's

• St Helens

• Crew Member

  • Jul 2002 - Jul 2005

  Duties included:  greeting customers, taking orders and serving food  dealt with customer complaints in a polite and effective manner  handling cash and cashing up tills  training new staff members  general domestic duties and stock control Duties included:  greeting customers, taking orders and serving food  dealt with customer complaints in a polite and effective manner  handling cash and cashing up tills  training new staff members  general domestic duties and stock control