Regulatory Affairs Director, New Business (JO255260 WH)

to ensure, in close interaction with the Corporate Regulatory Affairs Asia Pacific Region team, the regulatory activities supporting Asia Pacific Business Development projects and Asia Pacific Goa Development Center projects

provide the regulatory expertise necessary to assess project regulatory feasibility and dossiers

develop registration strategy according to AP business priorities and available data

implement validated registration strategy up to the registration approvals in the targeted AP markets

ensure the regulatory maintenance for the related local products in compliance with Group and local regulatory provisions

ensure validation from CRA AP Region is obtained before dispatching regulatory position paper (regulatory feasibility assessment and defined registration strategy) or conducting regulatory survey within countries)

Strategic Role

Commercial Exposure

This is one of the world's leading pharmaceutical companies with a worldwide presence across five continents.  It is now looking for a dynamic Regulatory Affairs Director, New Business for the Asia Pacific region.

Pharmacist degree (Bachelor's Science + advanced studies) and/or Medical degree

minimum ten years regulatory and project experience

experience in commercial operation organization

market and customer knowledge, legal and regulatory knowledge of generics in countries

project management skills, analytical and strategic thinking, results orientation, written and verbal communication, good organizational awareness and collaboration skills

knowledge of the pharmaceutical and generics market, knowledge of related legislation and regulations surrounding the marketing and distribution of pharmaceutical

If you would like to apply for this role or find out more, please apply online or contact Wendy Heng at Robert Walters on +65-65383343 or s&m-mm@robertwalters.com.sg, quoting the Job Reference SNG-JO255260.  Web: www.robertwalters.com.sg