about 1 year ago
Job title: Regulatory Affairs Associate Director, China Markets
A highly reputable Biotech in Berkshire are seeking a Regulatory Affairs Associate Director to cover the China Markets for their innovative portfolios.
- Responsible for delivery of regulatory strategy for specific development products for China, working closely with partner and affiliate counterparts
- Oversight of affiliate and CRO support and associated activities, including contract negotiation, budget planning, invoice tracking etc.
- Support and lead agency engagements with China CDE - including strategy agreement
- Participate in discussions and regular forums with regulatory, global R&D and clinical teams to support establishing and executing optimal China clinical development strategy for specified development products
- Experience working within APAC or China markets in essential
- Minimum 5-7+ years pharmaceutical/biotechnology industry experience in European or major International markets
- Ideally previously lead or participated in major agency meetings (i.e. EU/US/Japan/China/Brazil), including material and team preparation
- Experience and knowledge in the preparation of major regulatory submissions (NDA, orphan applications, pre-submission/scientific advice meetings)
Salary and benefits:
A highly competitive salary, car allowance, annual bonus, pension plan and private healthcare are on offer.
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org