Head of Regulatory Affairs & Quality

Location: Boston, MA

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Out client is an exciting cell therapy organization going through a very exciting period of growth, leading to the need for a Head of Regulatory Affairs & Quality to join the team.

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Reporting to the CEO, you will be responsible for formulating the overall strategy and tactics to achieve the organizations regulatory goals. Furthermore, you will oversee the development and implementation of the Quality Management System and CMC-related Quality activities throughout all stages of the clinical development lifecycle through to commercialization. This is a great opportunity for an individual to stamp their mark on the overall company strategy moving forwards.

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To be considered, we are looking to speak to individuals that hold the following skills, knowledge & experience:

• 15+ years’ experience within the Life Science sector (Pharma, BioTech etc.), with a number of years in a senior leadership role.

• Experience within Cell Therapy environments (Gene Therapy a plus)

• Robust knowledge of US cGMPs and global GMPs

• Strong stakeholder management skills dealing with regulatory authorities such as the FDA, EMA etc.

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If this potentially sounds like the next step your career, please apply today so that Chris Sinclair at RBW Consulting can review your profile and be in touch to discuss next steps.

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Package: Negotiable base + fantastic benefits