Achieva Group Ltd

Technical Regulatory Team Member

Location
Switzerland
Salary
CHF0 - CHF79 per hour
Posted
02 Feb 2021
Closes
04 Mar 2021
Ref
BH-25434
Contact
Amy Macfarlane
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Our global pharmaceutical client has a new vacancy for a Technical Regulatory Team Member
 
Description:
In the role of Technical Regulatory Team Member, you are contributing to the development and execution of regulatory strategies and the sustainment of regulatory compliance at manufacturing sites. The focus of the Technical Regulatory Team Member is on enabling global CMC-development leading to successful global commercial registration and/or effective management of post-approvals changes and product lifecycle including dossier preparation.

This role deals with the technical regulatory part of the submission dossier, ensuring the proper regulations are followed for the manufacturing of active substance and tablets. This is not dealing with clinical regulations. It is an operational role where main tasks includes writing, review and coordinating RA documentation.
Perfect Candidate:
The perfect candidate is someone with around 5 years in a similar environment: experience with technical regulatory affairs, with CMC regulations and Health Authority management. The role is open because someone in the team is leaving and they need someone ready to start asap.
 
 
Must haves:
• 5 years’ of experience in pharma in Technical Regulatory Affairs
• Degree in chemistry or pharmacy or biology
• Hands on experience in the technical part of the dossier (dealing with CMC regulations)
• Health Authority management, extensive knowledge of regulations and guidelines of major regions (e.g. ICH, FDA, EMA, WHO)
• Used to global matrix environment
• Proficiency with a wide range of data/information (CMC, clinical, non-clinical safety, DMPK, quality, manufacturing, business operations in this area)
• Fluent in written & spoken English
  • Experience participating in global product teams is a plus.