An excellent opportunity has arisen for a Head of Regulatory Affairs to join a world-wide biopharma organisation who are focused on changing the lives of patients living with severe diseases. As the Head of Regulatory Affairs, you will collaborate with all regions on global regulatory strategies within therapeutic/disease areas of responsibility.

Job Responsibilities:

• The responsibility to drive a culture of excellence and motivates employees to perform at their highest ability.
• Accountable to Recruit, develop, and retain highly talented and skilled regulatory scientists, labeling, advertising and promotion staff and regulatory intelligence and policy staff.
• You will ensure regulatory resources are provided for early and late stage development and life cycle projects (in conjunction with the GRL).
• To lead special regulatory projects/process initiatives of high complexity, ensuring global alignment.
• To provide regulatory leadership specific to the US therapeutic/disease area strategies to PVU leadership.
• Responsible to ensure that regulatory therapeutic/disease area strategic options, assessments, and risks specific to the US are communicated to the PVU.
• Accountable for achieving EMEA regulatory alignment for disease area regulatory strategy with input from PVU leadership, GRLs, and Regional Leads.
• Communicate with Global Business Development regarding TA Due Diligence assignments and provide input to due diligence projects as required.
• Awareness & application of global regulatory environment within the EMEA region (e.g. Health Authority guidance, new approvals, overall regulatory landscape).
• To provide high level strategic EMEA regulatory direction and mentorship to GRLs including general regulatory strategies, regulatory strategic development plans and risk assessments, regulatory critical issue management.
• To act as interface between PVU and EU PVO Leadership teams and GRA and build partnerships with PVU leadership and other PV Practices and Regions to ensure that strategic business goals are met through the sharing of knowledge and the provision of appropriate resources.
• Any other assigned duties.

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