Manager, Regulatory Affairs

hace 2 semanas

Ciudad de México Biogen A tiempo completo

**Job Description**:**About This Role**Reporting to the Sr. Manager, Regulatory affairs, the Manager supports all regulatory strategies creating tactics for new products at local and global levels.**What you will do**:- Responsible for precise and aligned communication with local teams and global Regulatory team.- Coordinate all post-registration changes for registered products.- Coordinate product renewals on due date.- Request and organize all GMP Inspections at international manufacturing sites and related renewals based on local sanitary dispositions.- Request and organize Sanitary Agency´s Meetings: pre-filing, technical queries discussion, New Medicines and Inspection clarifications.- Coordinate and ensure products labeling update.- Ensure Regulatory governance (spreadsheets, Regulatory SOP´s, documentation filling).- Collaborate cross functionally with other areas in the business and maintain regulatory updates/communication with all areas- Monitor additional clarifications related to initial reports to Global PV team.- Support Regulatory Area with RMP per product and assure the availability of most recent version of this document.- Support Medical team with all issues /questions related to safety of Biogen Products portfolio.- Direct support to Regulatory area with labeling changes due to safety issues.**Qualifications**:- Degree in Pharmacy or Biochemistry.- 6 years of experience in regulatory environment.- Fluency in English.- Good skills in informatics programs: Excel, Word, Power Point, etc.**Preferred Qualifications**- 6+ years of experience.- Previous Management experience.Additional InformationOur mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

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