Associate Director Regulatory Affairs

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My client, a global giant within Medical Devices has opened a new vacancy within their Regulatory Affairs team and are actively seeking to recruit an Associate Director Regulatory Affairs to their team on a permanent basis in Berkshire

The Role:

Responsible for the leadership and strategic direction for the R&D and CDO teams in support of Product Portfolio.

Working across a complex portfolio, will involve working on diverse registration/regulatory requirements across multiple global markets.

This will interface with functional members of the assigned category project teams (e.g. R&D Category Director, Commercial Category Director, Clinical/Medical Affairs, PMO, Innovation) to ensure flawless design and execution of global regulatory strategies in compelling stakeholder friendly language to support the global business objectives

Skills/Experience Required:

Educated to honours degree level in a scientific field or equivalent experience

Relevant Regulatory Experience and knowledge in NPD and dossier/technical file creation and global registrations.

Experience in different regulatory classifications (where appropriate) Knowledge of the Regional and Global regulatory environment and how it impacts regulatory dossiers and registration.

Experience in preparing and submitting dossiers, variations and renewals.

Understanding of global product development practice, rules, regulations and guidelines.

Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries.

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.