Job Ref: 212864418

Date: 2020-12-05 09:45:12

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The Director, Regulatory Sciences will formulate regulatory strategies and recommendations for the resolution of complex issues for clients and will lead the process in the development of regulatory submission, including but not limited to; MAA’s, Orphan and PIP applications, Accelerated and Conditional approvals. Additionally, the Director, Regulatory Sciences will pro-actively identify new regulatory trends and challenges and predict the effect of changes on regulations, policies and procedures. They will conduct due diligence on behalf of clients and develop risk management recommendations, build collaborative relationships with key stakeholders and manage the internal and external teams responsible for delivery and develop junior associates.

Essential Functions Include:

* Leading the development and implementation of regulatory strategies to realise the commercialisation of healthcare products.

* Strategic project shaping and leading of process preparation for EMEA submissions.

* Review and approval of audit and submission documentation.

* Briefing of clients and internal project teams.

* Leading and influencing frequent interactions for pre-submission activities with both EMA and national regulatory agencies.

* Leading client meetings and conducting client liaison on an ongoing basis.

* Provide scientific insight for new business pitches and proposals.

* Line management for junior team members

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