Medical & Regulatory Affairs Manager

Ethiopia, Addis Ababa

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Roche Ethiopia is looking for a Medical & Regulatory Affairs Manager who will be responsible to develop and implement the overall medical plan for Ethiopia and ensure Roche obtains timely regulatory approval for its products. He/ She should have least three (3) years’ experience in medical & regulatory function. Experience as healthcare worker is an added advantage.

Key responsibilities

  • Develop and implement the overall Medical plan of Roche Ethiopia.
  • Manage relationship with Therapeutic Area Experts and professional associates of healthcare workers.
  • Medical expertise and customer insights to the brand team
  • Provide medical information upon request.
  • Maintain relationships with patient organisations and provide information to patients and their associations.
  • Ensure Roche obtains timely regulatory approval for its products in Ethiopia as well as expiring approvals are timely renewed.
  • Manage relationship with external and internal regulatory stakeholders.
  • Ensure regulatory requirements eg for packaging or patient information leaflets are timely known and implemented.
  • Support Pharmacovigilance by ensuing collection of safety information from all sources in the local affiliate and timely provision to the hub
  • Support Pharmacovigilance ICSR processing regarding translations, follow-up requests, local regulatory reporting and other requests.

Education qualification

  • University degree in University degree in Medicine, Pharmacy or similar field.

Competencies

  • Core behaviors: Walk the talk (Accountability) / Be brave (challenge the status quo) / Do it right (serving others),
  • Proven ability to demonstrate Roche Values
  • Leadership and management skills / Organization, planning, strategic thinking, influencing and communication skills.
  • Proven ability to interact well in a multi-functional team setting.