Careers  Career Opportunities  Regulatory Affairs

Regulatory Affairs

Specialty Regulatory Affairs
Scope of Responsibility Entry Level
Residence Kuwait
Closing Date:30/09/2020
Job description:
Responsible for the product registrations and renewals, as well as the fulfillment of all regulatory requirements to import, market and utilize AMICO products.

Job Description but not limited to the ff:
1. Analyze broad scope implications of changing regulations and guidance.
2. Registration of required classified products.
3. Serve as Central Reference point for all regulatory affairs for both AMICO and its suppliers.
4. Assist as needed in providing necessary documentation or information to support import and export.
5. Monitor impact of changing regulations on submission strategies and update internal stakeholders.
6. Assist in regulatory due diligence for potential and new acquisitions.
7. Tender coordination and follow up with internal sales teams and government sectors
8. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.
9. Represent AMICO to authorities / entities whenever required.

Desired Skills and Experience:
- Education (minimum/desirable):
o Bachelor degree or equivalent

- Languages:
o Arabic and English Written and Spoken fluency are a must

- Skills:
o Knowledge of the regulatory affairs in the different Middle East countries

- Experience/Professional Requirement:
o Minimum 2 years industry experience in the medical device / pharmaceutical area managing regulatory affairs in the Gulf countries