Regulatory Vacancy At Sanofi Egypt
Position Title:
CHC Regulatory Senior Specialist- Egypt
JOB PURPOSE:
Prepare and implement the regulatory plans in a timely and accurate manner
Close follow up with internal and external stakeholders to achieve regulatory priorities
Act as a focal point between SANOFI and the Regulatory authorities
Secure the submission and approval of variations for products portfolio on timely manner
Secure the submission and approval of renewals for products portfolio on timely manner
Secure the submission and approval of New launches for products portfolio on timely manner
KEY RESPONSIBILITIES AND DUTIES:
Planning:
Preparation of the regulatory documents required for submission of Variations, renewals and new launches and working closely with the DRA / GRA team to ensure that the documents are valid and complete at the time of submission (CPPs, registration licenses, pricing certificates, variations approvals, etc.)
Working with different internal/External stakeholders in order to receive the documents required for issuing all required approvals on timely manner.
Submission:
Filling in all MOH forms and templates required for submission.
Following up and answering MOH queries in timely manner until granting the final approvals and sharing them with all concerned stakeholders
Database:
Developing and maintaining an accurate and up-to-date database for all activities (variations –renewals- new launches – labelling updates )
Developing and maintaining an accurate and up-to-date database for Monthly TCs done on monthly basis with different stakeholders
Developing and maintaining an accurate and up-to-date database for Monthly New launches meeting
Others:
Perform other duties as assigned.
Respect of company’s values, code of ethics and social charter.
Respect of personal data protection charter.
Responsible for applying the HSE related requirements for the company in all related working procedures.