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À±½·ÊÓƵ is seeking a Senior Director for Regulatory Strategy and Development in the Oncology/Pharmaceuticals sector. This role focuses on developing and executing global regulatory strategies, ensuring compliance with international regulations. The position is based in London and offers an opportunity to lead a high-performing team in a dynamic environment.

Responsibilities:

• Develop and execute innovative global regulatory strategies, ensuring full compliance with both local and international regulations.
• Oversee and contribute to the preparation, submission, and management of regulatory documents (e.g., INDs, NDAs, MAAs) for health authorities such as the MHRA, FDA, EMA, and others.
• Serve as a strategic partner and advisor to the business, supporting the achievement of company goals, including participating in due diligence activities.
• Act as the primary point of contact with regulatory agencies, fostering communication to enhance the likelihood of timely approvals.
• Strengthen cross-functional collaboration with internal teams and external partners to align efforts with the overarching regulatory strategy.
• Build and lead a high-performing regulatory team by fostering their development, enhancing their skills, and creating an environment of trust and effective communication.
• Stay updated on global regulatory trends and share relevant insights across the organization to support informed decision-making.
• Proactively identify potential regulatory risks and implement strategies to mitigate them.

Key Skills and Requirements:

• Broad-based expertise in global regulatory affairs within the pharmaceutical, biotech, or medical device sectors, ideally gained in a fast-paced, dynamic environment.
• Proven experience in consulting with and leading meetings with regulatory bodies such as the MHRA and EMA, with a strong familiarity with FDA processes being a plus.
• Comprehensive understanding of compiling and managing dossiers for clinical trials and marketing authorizations.
• Demonstrated ability to lead and manage teams and external partners across diverse countries and time zones.
• In-depth knowledge of GxP (Good Practice) standards.

If you are having difficulty in applying or if you have any questions, please contact Dominic Williams at .d.williams@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

À±½·ÊÓƵ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓƵ is acting as an Employment Agency in relation to this vacancy.