Senior Manager Regulatory CMC – Small molecules ** BRUSSELS AREA

Reference: CBC503

Expiry Date: 07-09-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Belgium

Apply for position

Job Description

About the Client:

My team and I are working for a medium-sized global bio-pharmaceutical company with a good count of marketed products and one of the first to register a mAb in Europe, but now are supporting multiple NCEs in Phase 1-3, for global development as well as preparing first MAAs and managing line extensions for small molecules and hence they are looking for a CMC Senior Manager Regulatory Affairs.  

About the Role:

You will take responsibility for the regulatory CMC support of Small Molecule products throughout the Lifecycle.

As well, you will define strategy, planning and preparation of regional specific CMC submission documentation for assigned geographical regions and contribute to the preparation of global submission documentation to deliver timely approvals to meet business needs.

Also, you will be leading and/or provide regulatory CMC input to all Health Authorities (HA) interactions on CMC matters in assigned regions as delegated by Global Regulatory CMC Lead and agreed with the GRA Leadership Team and the operating units.

As one of the CMC experts of the team you will ensure that all CMC regulatory strategy, risks, and overall plan for assigned regions to GRA Teams, Technical & Supply Operations (TSO) Teams, Development and Commercial Teams align with the Global Regulatory CMC Lead Strategy.

Your Experience:

  • Educated to a Master’s level, in a relevant life science or business-related discipline.
  • Experience in the pharmaceutical industry or a regulatory authority CMC review capacity.
  • Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities.

Package & Benefits:

Our client is offering a strong relocation package for all EU nationals, with disturbances allowance and support for naturalization as well as a tax ruling program for you to decrease your taxes. The package they offer comprehends a very decent basic salary, with a 10-15% bonus levels before multipliers and stock options for the higher grade.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Javier Monfort on +44(0) 207 801 3385, or send a full CV to jmm@advtalent.com. As I know the hiring manager, I will support you throughout the interview and on-boarding experience.

GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.