21 days ago
I am currently working with an exciting rare disease biotech company that is in a major phase of growth. This is an excellent new opportunity for a Head of Regulatory (EMEA) Affairs to join their site in Berkshire.
The successful professional will provide leadership, strategic planning, and resource management for the EMEA Regulatory Affairs organization with the objective of ensuring that all development and post-marketing regulatory activities comply with applicable legislation and aligned with company goals.
Key Responsibilities but arent limited to:
• You will be accountable for recruiting, training, mentoring and reviewing the performance of RA staff.
• Oversee the development and maintenance of Project and Product Regulatory Strategy in alignment with commercial and company strategy.
• Ensure that RA activities are planned to comply with the relevant legislation and guidelines in respective territories.
• Ensure that regulatory submissions are reviewed and approved in accordance with relevant governance prior to submission
• Oversee regulatory submissions process to ensure that high-quality Marketing Authorisation Applications (MAA’s), Clinical Trial Applications (CTA’s) and responses to questions are prepared and submitted in accordance with Company objectives.
• Responsible for developing and maintaining an effective and collaborative relationship with competent authorities in the EMEA region.
• Accountable to create the overall EMEA Regulatory action, budget, and resourcing plans and support the creation of global plans in consultation with the Head of Global RA.
If you are a Regulatory Affairs Director or Head of looking for a new challenging role, get in touch!