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Regulatory Manager

Pharmaceutical

Mauritius

Permanent

Updated July 13, 2010


This is an excellent opportunity to join a market leading pharmaceutical company in their global head office in Mauritius as Regulatory Manager.

The role

Reporting to the Technical Manager, you will be tasked with performing regulatory activities for divested products in all licensed countries.

Key accountabilities will include:

Leading a team of dedicated RA professionals
Reviewing dossiers, regulatory documents, and responding to deficiencies
Organise and deliver training sessions for project teams
Liaising with regulatory agencies, partners and customers
Proactively manage the technical and quality issues relating to the preparation of submissions
Maintenance of the record of post registration technical variation
Labeling changes and advising the labeling team accordingly

This role is based in Mauritius offering a high quality lifestyle within an expansive expat community. Candidates must be willing to relocate to the jurisdiction and to travel internationally from there as and when required.

Who we're looking for
Above all else we seek an individual who has the ability to make a difference. You will be noted for your problem solving and horizon scanning abilities. The ideal candidate will have a demonstrable track record of success gained in a regulatory affairs department of a reputable pharmaceutical organisation.

In addition, you will have:

A knowledge of ICH, US, EU and GMP guidelines
Proven experience of preparing dossiers in CTD
Experience of authorisation applications in Latin American and European Union

Candidates with a bachelors or post graduate degree in pharmacy are particularly sought as are those who have worked within an international context.

This is a very exciting opportunity for a candidate who wants to apply their skills and expertise to an organisation that encourages and rewards results driven performance.

About our client
Aspen is Africa's largest pharmaceutical company. The Group's commitment to investing in the future is demonstrated through the expansion of its global footprint, the enhancement of manufacturing capabilities and standards, as well as by the strengthening of its product pipeline.

Aspen has established its international holding company, Aspen Global, to hold its international investments and rapidly growing worldwide trading business. Against this backdrop, they are seeking to recruit a Regulatory Manager for their office in Grand Bay, Mauritius. Aspen Global Incorporated is an international and expanding organisation with businesses in Germany, Australia, East Africa, India, Middle East, Latin America, South Africa with their global head office in Mauritius.

What's on offer
Relocation and benefits are an addition to a competitive package (in US Dollars).

Please send a copy of your CV in English to the contact details below.

Paul Holloway
paulholloway@michaelpage.com
+44 (0) 20 7269 2477

Job Ref: 13079194

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