Job expired on 21.07.2015.
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Our Client is international pharmaceutical company that provides medicines in hospital, prescription and OTC programs. For further development of their local activities, they are looking for a proactive and experienced professional for the position of

Regulatory Affairs Manager

  • university degree in Medicine or Pharmacy
  • 3+ years of managerial experience within regulatory affairs within international environment
  • familiarity with quality assurance and compliance shall be appreciated
  • fluency in English and strong PC skills
  • proactive, adaptable personality, with strong networking skills
  • capability to navigate in a matrix environment and change agility
  • global overview, but hands-on, operative approach and can do attitude
  • timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local Health Authorities in Serbia and Montenegro
  • maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations
  • accurate and compliant labeling translations and layout development
  • follow up on regulatory changes and market trends related to regulatory affairs 
  • supports the further business development in line with position duties and competences, locally, regionally and globally
  • nurture relationships with internal and external regulatory stakeholders
  • support launching and market presence in regards to the regulatory strategy
  • secure regulatory compliance by maintaining global regulatory tracking systems
  • act as a Drug Safety Officer for Serbia and Montenegro
  • participation in establishing and maintaining of relevant SOP to secure that the current regulations are complied with
  • development and execution of Quality Improvement Plan
  • local implementation of Global Compliance Initiatives
  • reporting to the Medical Director
Our Client is offering a responsible position within a developing international environment, along with continuous training and self-development opportunities and adequate remuneration package. 
If you believe you meet the requirements of this challenging position, please send us your CV and application letter in English, with full confidentiality.
HILL International, Beograd, Ruzveltova 45, tel/fax: +381 11 3294 500
Job duration: 02.06.2015.