معاون تنظيمي

Sanofi

Sanofi

Responsible for the maintenance and regulatory compliance of the product portfolio under his/her care.

Responsible for all regulatory activities related to products assigned to a specific Business and/or therapeutic class, of the subsidiary.

In alignment and by delegation from the Regulatory Head, and/or responsible pharmacist, he/she represents the products under his/her care to the local authorities.

Participate in the development of the subsidiary's regulatory strategy and provide regulatory expertise to local and global project and business teams, for products in development and/or marketed, in compliance with rules of compliance and ethics.

Ensure the validation of artworks at the local and global level, and monitor the implementation of variation labeling within pre-established deadlines.

Ensure the timely updating of regulatory databases for the portfolio for which he/she is responsible.

Verify and validate promotional materials with Marketing and Medical in accordance with global processes and local regulatory procedures.

Ensure the preparation and monitoring of systematic release files for batches of imported products.

Participate in the drafting and validation of procedures.

Monitor regulatory changes in the external environment, and ensure competitive intelligence by assessing the potential impact on the business.

Participate in the preparation of files related to calls for tenders, where applicable.

قراءة المزيد

https://sanofi.wd3.myworkdayjobs.com/en-US/SanofiCareers/job/Alger/Regulatory-Associate_R2830429-1