Regulatory and Tender officer
Location | Addis Ababa, Ethiopia |
Date Posted | August 6, 2020 |
Category | Engineering Pharmacy |
Job Type | Full-time |
Currency | ETB |
Description
About us:- Orbit Health Solutions plc is a firm registered in Ethiopia and located in Addis Ababa. The company is engaged in trading of diversified product lines of Medical
Job Brief:
The regulatory affair ensure that orbit Health solutions supplier’s products comply with the Ethiopian regulations and Keep up to date with national and international legislation and guidelines. This post requires a person with national and international bid /tender document preparing knowledge and experience.
Responsibilities:
- Ensure that our supplier’s products comply with the regulations.
- Keep up to date with national and international legislation, guidelines and customer practices
- Collect, collate and evaluate dossiers for registration submission.
- Prepare submissions of license variations and renewals to strict deadlines
- Monitor and set timelines for license variations and renewal approvals
- Advise suppliers on regulatory requirements.
- Provide strategic advice to senior management throughout registration of a new product.
- Review company practices and provide advice on changes to systems
- Maintain good and regular contact with regulatory authorities.
- Negotiate with regulatory authorities for marketing authorization.
- Ensure Orbit Health Solutions PLC (OHS) licenses are adhered to.
- Check Tender websites, submit to managers with recommendations and decide the feasibility of the bid.
- Prepare and submit Tender document.
- Attained tender readings and report the result.
- Related job assigned by managers.
Job Requirements
Experience
- 2-3 years’ experience in medical and pharmaceutical trading industries in regulatory position or organizing dozier, submitting to FMHACA for registration, follow it and get registration certificate.
- Tender document preparation experience
Qualification
- B.SC Degree from recognized University by Bio Medical Engineer, Pharmacy and related
Products Range knowledge May include:
- Medical Devices and Supplies
- Pharmaceuticals
- Veterinary medicines
- Complementary medicines
- Agrochemicals
- Pesticides
- Therapeutic devices
- Cosmetics.
Skills and Attributes:
- Ability to manage and prioritize a complex and varied workload
- Self- Sufficiency and problem solving skills
- Ability to respond positively to unexpected changes
- Ability to deal with people in a clear and diplomatic manner
- Ability to speak to a wide range of audiences on complex issues
- Networking Skills
- Ability to produce work product that is free of errors
- Ability to use technology as required.
Applying Instructions
interested applicant can send their CV and copy of diploma certificate to e-mail below;
Phone number: +251 116 507 335
Address: TK building, 6th floor, office no. 601,602,603 at Commercial Bank of Ethiopia entrance side.