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Senior Director Regulatory Affairs
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Senior Director of Regulatory Affairs – UK remote
Are you an expert within the European Regulatory Pharmaceutical Markets? Have you got experience leading successful approvals of MAA’s from the EMA?
We are proud to partner with a global market leading biotech who have developed a state-of-the-art technology platform. They have technologies at clinical trials ongoing through to Phase 3.
We are looking for a Senior Director of Regulatory Affairs, who will report into the senior leadership team and play a key role for the company strategy & direction by acting as their primary liaison to the EMEA, and wider EEA.
You will be integrating existing and emerging projects in clinical development, within the wider European market as these go through clinical trials. Due to the nature of this role, we are looking for someone situated within the UK, and the role will be remote, with occasional travel into the US and EU.
In this role you will be:
- Planning, and executing strategies regulatory strategy across the EU/ EEA for products at all stages of development.
- Acting as the primary liaison to the EU / EEA for the companies forthcoming products, and projects.
- Responsible and accountable for leading MAA or CMA submission effort across all necessary functions.
- Provide strong oversight and management of vendors and CROs as it relates to the Regulatory function and in coordination with appropriate clinical team members.
- Monitor and interpret EU and other European countries’ relevant policies and guidance, assess the impact on company’s business, and partner with the Chief Regulatory Officer to define or refine strategies based on new guidance or policies.
- Function as the expert internally for regulatory requirements in European regions for product development.
To be successful in this role you will need to have:
- A master’s degree within a related Life Sciences field, ideally you will also have a PhD in a related field. We will also consider candidates with a sufficient level of experience.
- Extensive experience at director level or higher within Regulatory Affairs.
- Proficient experience of working within Pharmaceutical European Regulatory Markets.
- Demonstratable experience of leading successful submissions & approvals of MAA’s from the EMA.
- Direct experience leading formal meetings with the EMA & wider EEA health authorities.
- Ideally, have recent experience within biologics in a RA capacity.
You will be joining a company making a significant leap forward, and one dedicated to equality & diversity at the forefront of their culture.
If you are interested in this role, or would like more information, please contact:
