Expiry Date: 23-03-2021
Category Regulatory Affairs
Job Type: Contractor
Contract - Regulatory Affairs CMC Consultant Biological - EU & International Regions
Location: Netherlands but home working available until post COVID
We have a Regulatory Affairs CMC contact role for a global Pharmaceutical Company with home working options available.
You will operating in a Global Regulatory Affairs department leading and managing major RA CMC activities around MAA’s and major lifecycle
initiatives for EU and major International markets, for 2 leading products and their API’s.
Strategy, planning, definition of content, preparation, review and approval of global CMC submissions for assigned projects/products to achieve timely approvals to meet business needs.
Identifying supporting CMC documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
Writing and approval of CMC sections for submissions (i.e. for briefing documents, clinical trial applications, registrations, post-approval submissions, PIPs) and responses to health authority questions in line with agreed global regulatory strategy, and within agreed timelines.
You will be joining a highly experienced, but very friendly regulatory team in a company with a relaxed and flexible way of working. The rate is very good and the projects are interesting and require good amounts of leadership and strategic input. Strong experience in Regulatory CMC leadership, submissions and lifecycle maintenance is essential for the role.
The contract will last 12months, with a strong possibility of an extension.
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