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Online Laboratory Magazine
03/09/2021

Regulatory Affairs Manager for RCC APMA (m/f/d)


  • Define and implement regional regulatory strategy in registration and approval for new pharmaceutical products in respective countries and ensure maintenance as appropriate
  • Provide strategic guidance and direction to Sandoz development/maintenance, ComOps, TechOps, Third parties about the regulatory topic
  • Act as a primary interface between respective Sandoz country organization and Sandoz global functions
  • Support additional products like VAMs, branded generics, and explore regulatory environment in the country of responsibility for more opportunities.
  • Accountable for full compliance of internal regulatory tools and systems
  • Accountable for regulatory compliance in respecting cluster
  • Representative for the country to global product development, project management, portfolio and launch management
  • Accountable for evaluation of changes in local and regional regulator ion and provide assessment and impact on Sandoz portfolio to the management
  • Responsible with the responsible teams for due diligence activities, divestment support, document review and any additional responsibilities that may be required from regulatory
  • Bachelor degree in Pharmacy, Pharmacology, Biochemistry, Chemistry, medicine or any other relevant disciplines
  • Minimum 3 - 4 years of regulatory experience at global or country level, preferable working in the generic field within emerging markets
  • Solid understanding of generic drug development process, ICH guidelines, local and regional regulatory with ability to interpret and apply policies


» Job description


Employer:
Hexal AG
Location:
83607 Holzkirchen
Temporary:
Yes