Quality Assurance and Regulatory Consultant
An excellent pharmaceutical firm is currently searching for a Quality Assurance and Regulatory Consultant to work in their Switzerland Office, providing support for clinical investigations. This is the ideal opportunity for a dynamic individual looking to positively contribute to the development of medicine.
- Advise the Therapeutic Leader on necessary regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates
- Drive understanding of central and national regulatory requirements
- Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area
- Provide input for developing and updating the Target EU SmPC based on an understanding of the implications of regional regulatory strategy for labelling
- Ensure appropriate implementation of scientific advice / Regulatory Agency comments into development and life-cycle management plan
- Liaison with Regulatory Agencies and Local Operating Companies
- Determine timing and strategy for Regulatory Agency meetings and scientific advice
- Determine resource requirements for assigned projects and anticipate needs for major filings
- Negotiate labelling with Regulatory Agencies, going through each of the back-up strategies if necessary
- Input in document and process development Advise team on required documents and processes to support Regulatory Agency contacts and submission
Skills and Requirements
- Graduated with a degree in a scientific field (e.g. Biomedical Engineer, Pharmacist or Scientist).
- 2-3years experience in the conduct, management or evaluation of clinical trials or with the development or regulation of healthcare products in the European market.
- Excellent written and verbal communication skills
- Fluent English is mandatory, other European language would be desirable
- The ability to build and maintain excellent working relations with clients and colleagues
- Take initiative and work independently with minimal direct supervision and to organize heavy workloads effectively, successfully managing multiple tasks with competing demands, conflicting priorities and tight deadlines.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact James Wilson at +44 203 762 2703 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.