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An exciting opportunity for a Vice President of Scientific Affairs and Regulatory Engagement. Responsible for ensuring scientific quality in product submissions, leading teams, and direct engagement with regulatory bodies like the FDA. Join a successful global business and make a significant impact.
You will be a key member of the senior executive leadership team within R&D, accountable for the scientific quality of product submission dossiers, and their successful approval by regulatory authorities.
Under your guidance and scientific leadership, you will be responsible for managing:
You will have full responsibility for the scientific content of future regulatory submissions, ensuring that all research and data are of the highest quality standards.
You will have a high level of autonomy, decision making responsibility and be expected to possess excellent communication skills in order to develop outstanding relationships with internal and external stakeholders and regulatory agencies.
Crucial to your success will be your ability to work closely with the FDA and other regulatory bodies to agree innovative scientific approaches and provide the internal leadership to convert this into a regulatory strategy to be followed and implemented.
Scientific standards will be established through a Quality by Design approach to all aspects of the research, including non-clinical and clinical assessment, behavioural studies, manufacture and post marketing surveillance.
Ideally you will have an innovative and pragmatic approach, a desire to make a difference and the ability to lead and motivate others through your passion and enthusiasm. Your communication skills will allow you to interact at all levels, share complex information and work closely with the executive leadership team and Board. You will provide scientific and regulatory leadership and ensure full compliance whilst appreciating when to consider a more creative and pragmatic approach whilst ensuring scientific integrity and robust data.
This is an exciting opportunity to join a highly successful global business, within a leadership capacity, in a highly visible capacity where the long term career prospects are varied and exceptional.
Location: Switzerland
Salary: Attractive Salary Package Commensurate with experience
Reference: PSL4021
Pharma-Search Ltd,
Company Number: 07441348