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