Senior Director - Regulatory Strategy and Development

Proclinical 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.

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