Regulatory Affairs Manager

4 weeks ago

City of London Greater London, United Kingdom i-Pharm Consulting Full time

Regulatory Affairs CMC Manager
Contract Length: Initial 12 Months - possibility to extend
Monday - Friday (onsite or remote flexibility)
Are you a seasoned Regulatory Affairs CMC Manager with a wealth of experience in the bio-pharmaceuticals Industry? We are seeking a skilled individual to take on the role of Regulatory Affairs CMC Manager to support global commercial post-approval submissions

Represent regulatory CMC at relevant site meetings and provide timely and accurate feedback to support site initiatives.
Manage the compilation of all necessary documentation for commercial regulatory CMC submissions and responses to questions.
Ensure submissions are of high quality and compliant with application regulations and guidelines governing the development, licensure, and marketing of chemical drugs, biologics, or gene therapies.
Participate in cross-functional project teams as a regulatory CMC representative for project-specific discussions.
Proactively identify issues and suggest appropriate strategies to mitigate risks.
Assist in the preparation for interactions with global regulatory authorities.

Experience of generating global regulatory strategy documents
Proven ability to lead SME team of authors to generate variation/supplement content enabling Right First Time approvals
Good knowledge of regulatory legislation and CMC guidance in EU, US and ICH markets, experience with international MAA and post-approval filings essential
Good knowledge of regulatory submissions for biotech products, experience with Agency interaction preferred

If you possess the expertise and leadership qualities required for this challenging yet rewarding role, please submit your application including your CV to jkirlew@i-pharmconsulting.Join us in driving excellence in pharmaceutical commissioning and qualification in Dun Laoghaire, Ireland

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