Head of Regulatory Affairs

A pharmaceutical business seeks a new Head of Regulatory Affairs with experience in the Generic drug market to lead the Regulatory Affairs function and provide strategic input into all related activities.

There is a broad portfolio across various therapeutic areas, with a busy pipeline and constant investment in their growth plans. This means lots of strategic input from the Head of Regulatory to ensure the best procedures and route to market, working with internal teams and external agents, contractors and affiliates.

Key Elements of the Role:

• Strategic Input- provide strategic regulatory coordination for all product development, ensuring compliance with relevant UK and EU legislation and guidelines to ensure successful product launches, while maintaining an existing portfolio of products.
• Team Management- Creating and supporting development plans with each team member, giving them the tools to succeed in their roles
• Compliance- ensures that Regulatory meets legal and compliance requirements, ethical standards and SOPs.
• Broader Leadership- collaboration with all external stakeholders and internal business disciplines to facilitate successful growth

Essential Qualifications/Skills:

• Scientific Degree or equivalent business experience in the Generics market
• Extensive knowledge of the regulatory environment and the impact of current issues.
• Extensive knowledge of relevant UK and EU legislation procedures and guidelines.
• Strong interpersonal skills at all levels, including people management, leadership, and stakeholder interaction
• Experience in leading a successful team.
• Ability to successfully manage numerous and complex projects concurrently
• Can create strong working relationships with internal and external stakeholders

This is a small and friendly company, who work in a nimble, collaborative way to bring a range of products to patients across various therapeutic areas- with ongoing new product pipeline ensuring variety and regular new challenges.

The office is in South West London, but 50/50 WFH will be the norm post-COVID.

Please apply today to be considered or contact Katie Dunbar on +44 (0)1293 584300 or katie.dunbar@rbwconsulting.com for more information.