Global Regulatory Affairs CMC Associate

A leading pharmaceutical healthcare company are currently recruiting for a Global Regulatory Affairs CMC Associate for a 6 month interim period.

Ideally they are looking for someone to start within a months notice and have the following experience:

-Deliver global regulatory affairs CMC project activities, as required, by effective coordination, strategy and implementation.
- Prepare and deliver regulatory submissions (CTAs, INDs,MAAs, NDAs, annual reports, variations, renewals, Response to questions) in line with defined CMC Regulatory plans.
- Work collaboratively with appropriate company personnel and contractors (when required) to co-ordinate the regulatory work stream elements for CMC activities.
- Liase with Regulatory Authorities as required.
- Maintain documented regulatory project plans in line with best practice recommendations within Global Regulatory CMC department.
- Update Functional leads and maintain transparency of information across Regulatory function.
- Facilitate and support the development and documentation of revised regulatory processes in line with global processes within the CMC team.
- Support the implementation of change control activities within the Global Regulatory CMC function, as appropriate.

My client is looking to set up telephone interviews within the next couple of week so if this is a role that you might be interested in then please don't hesitate to contact Peter Duvall on 02074695255

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