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Director Regulatory Affairs

  • Job type: Permanent
  • Location: Hong Kong
  • Salary: $300000 - $350000 per annum
  • Job reference: EPM
  • Sector: EPM Scientific, Regulatory
  • Date posted: 18/07/2017
  • Develop and lead the registration strategies in the region to ensure timely registrations for RRP products
  • Develop and lead the registration strategies as required, for other  in the region
  • Ensure  of regulatory  for product launches and priorities in the region are met
  • Ensure on-going regulatory product compliance of the RRP portfolio marketed in the region
  • Responsible respective affiliates in the region and direct all activities related to the development and implementation of regulatory strategies for NGPs to obtain registrations. This role will provide direction to the Central Regulatory Affairs function in order to establish registration requirements and define submission strategies. 
  • Required to work closely with Marketing and Sales to understand the market for registration purposes and will work closely with Corporate Affairs in the local market to implement registration strategies. 
  • He / she is expected to develop and maintain a network of relationships within the relevant regulatory authorities at the national levels in support of company's commercial objectives in the region. Must have the ability to engage with senior across the company to provide direction and input on matters related to the regulatory requirements for MRTP . Ensure on-going products compliance of the RRP portfolio marketed in the region.
  • Responsible for leading multi-year (3+) regulatory programs involving significant cross-functional activity with high visibility and high strategic importance.

Experience
  • 8-12  experience in regulatory affairs with direct experience leading registration strategies and direct interaction with regulatory authorities for successful new product applications, approvals and post-marketing changes. 
  • Demonstrated an ability to work within the industry to influence changes in broader technical and policy issues. 
  • At least 5 years experience at senior manager level and a record of effectively leading teams. 
  • Good knowledge of cGMP as well as GCP and pharmacovigilance a definite asset.

Qualifications
  • Scientific Degree, minimum an MSc or equivalent or a degree in a medical speciality (eg. Pharmacist, clinical pharmacology )

If interested in this role, please send in an updated CV/ resume along with salary, notice period and location to apply.a33ho1ggr29@epmscientific.aptrack.co.uk or call me at +65 94790492.
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