A top 10 biotechnology company that operates in over 70 markets worldwide is looking for a Regulatory Emerging Markets Consultant. The company specialises in neurological conditions and puts a great emphasis on teamwork and delivering biological products.
- Responsible for the successful development and implementation of regulatory strategies for new submissions including post-approval compliance for in region/markets of responsibility.
- To provide support for Regional Regulatory Leads - responsible for new submission planning, strategy and implementation.
- Provide strategic guidance and regulatory leadership at project team meetings as well as represent the Global Emerging Markets strategy for assigned products in region.
- Identify and assess regulatory risks associated with the execution of regulatory strategies in assigned region/ markets.
- Define strategies to mitigate risks.
- Responsible for coordinating the preparation of the regulatory submissions and coordinating responses to questions from the Health Authorities
- Highlight key issues that may impact the execution of regulatory strategy across territories.
- Build and maintain effective relationships with both internal as well as external stake holders
Education and Experience:
- Minimum 4-5 Regulatory Experience preferably in the Emerging Markets sphere.
- Asia Pacific experience would be great
- Full lifecyle experience
- Safety Variations
- Working on New Submissions
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 call Peter Duvall on +44 203 0789 542 or upload your CV on our website www.proclinical.com.
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.