Hobson Prior is seeking a Regulatory Affairs Manager for a leading biopharmaceutical service provider. The successful candidate will be responsible for managing global regulatory strategies, ensuring compliance with regulatory requirements, and fostering relationships with regulatory authorities worldwide. This role also involves talent development within the team and risk management.

Responsibilities:

• Supervise global regulatory strategies and associated submissions and approvals.
• Achieve regulatory milestones for clinical trials, new submissions, and life cycle management.
• Manage company licenses and certifications.
• Review and approve CTD Quality dossier and responses to questions from regulators.
• Ensure strict compliance with regulatory requirements and company standards.
• Optimize the regulatory process and systems.
• Define and embed effective processes.
• Manage risk with disciplined regulatory compliance.
• Deliver regulatory policy and intelligence insights to support strategic priorities.
• Build partnerships with regulatory authorities through proactive engagement.
• Serve as a liaison between regulatory authorities and other company departments.
• Enhance team capabilities through effective coaching and talent development.
• Any other assigned duties.

Requirements:

• Experience in Regulatory Affairs within the biopharmaceutical industry.
• Knowledge across diverse therapeutics including Pharma, Vaccines, and Biopharmaceuticals.
• Comprehensive understanding of the global regulatory framework and requirements, with particular expertise in the USA, EU, and Korea.

Apply now:
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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