Alexa

Regulatory Affairs Manager - Fresenius Medical Care Asia Pacific Ltd. ONLY APPLY WITH THE RIGHT QUALIFICATIONS AND EXPERIENCE Masters in Pharmacy (M.Pharma) -Pharmacist Participate in the development of regulatory strategy. Maintain registrations in designated territories and complete other registration activities as required by company strategy.
Full-Time
Colombo
Working for international multinational company in Sri Lanka

Regulatory Affairs Manager - Fresenius Medical Care Asia Pacific Ltd.

Only apply with the right qualifications and experience. Masters in Pharmacy (M.Pharma) -Pharmacist

Participate in the development of regulatory strategy. Maintain registrations in designated territories and complete other registration activities as required by company strategy.

  • Apply the knowledge of company’s products / procedures / Good review practice to interaction with external customers.
  • Collect internal and external regulatory and competitive information and report to management team.
  • Communicate with other group companies, agents, external consultants and Health Authorities in order to expedite registration submissions.
  • Interface with various internal departments to coordinate activities related to product registration and post-registration compliance.
  • Review and approve registration dossier and other regulatory documents to ensure the data presented fully represent what is practically required. Coach subordinates to complete the whole process for new/ renew/ modification registration


Education & Industry experience:

   Masters in Pharmacy(M.Pharma), Pharmacists.

Position Experience:

   Minimum 3 years of experience in regulatory affairs roles in medical device or pharmaceuitical industry with NMRA Sri Lanka.

Skills and Competency:

   Good communication and interpersonal skills

   Good written and verbal communication skills in English

Good Computer skills, including Word /PowerPoint/Excel

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