Global Regulatory Affairs Specialist 498

About the job

We are seeking for a Regulatory Affairs Specialist responsible for ensuring the delivery of regulatory activities performed for one of our main pharmaceutical clients.

About us

Responsibilities

In close collaboration with the development teams and the subsidiaries (Gulf, Turkia and African countries), your mission is to guarantee the application of the Group’s international regulatory strategy within the framework of the constitution of the registration files and the product tracking.

As such, for the countries for which you are responsible, as Regulatory Affairs consultant you:

Participate in the preparation of registration, renewal and variation files for our drugs submitted to the Health authorities in eCTD format in collaboration with the teams in charge of the publication of the files,
Develop answers to questions from the authorities in collaboration with the departments involved,
Ensure regulatory monitoring of products on the market,
Provide regulatory support to local contacts and the Group’s departments (production, quality assurance, supply chain, etc.), particularly as part of the strategy for filing registration files for our oncology drugs.

Profile and Skills

Phamacist diploma is mandatory
around 5 years of experience in Global Regualtory Affairs
Familiar with electronic document and information management systems (eg Veeva, eRIMS, eDOC and MyDoc) and IT systems (eg MS Word, Excel, Power Point, Lotus Note and Outlook)
Excellent communication skills in English and Franch language is key for business continuity
Ability to work in a fast paced environment
Entrepreneurial mindset
Proactive attitude and able to work on own initiative as well as part of a team
Ability to prioritise different workloads/multi-task
Personal responsibility for ensuring a high standard of work

Global Regulatory Affairs Specialist 498

About the job

Group 10 Responsibilities

Group 13 Profile and Skills