Senior Manager/Director of Regulatory Affairs

2 weeks ago


United Kingdom PE Global Full time

PE Global is currently recruiting for a Regulatory Affairs CMC Manager for a contract role with a leading multinational Biotech client based in London – Fully remote within the UK. Regulatory CMC support for post-approval submissions for commercial products, predominantly biotechnology products and new international MAA filings predominantly in EMEA region. regulatory CMC at relevant site meetings and provide timely and accurate feedback to support site initiatives.
compilation and project management of all necessary documentation for commercial regulatory CMC submissions and response to questions. Ensure submissions are high quality; the content and format of regulatory submissions comply with application regulations and guidelines governing the development, licensure and marketing of chemical drugs, biologics or gene therapies.
in cross-functional project teams as a regulatory CMC representative for project specific discussions. identifying issues and suggesting appropriate strategies to mitigate risks.
in the preparation for interactions with global regulatory authorities
of generating global regulatory strategy documents.
ability to lead SME team of authors to generate variation/supplement content enabling Right First-Time approvals.
knowledge of regulatory legislation and CMC guidance in EU, US and ICH markets.
knowledge of regulatory submissions for biotech products.
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