Senior Technical Regulatory Affairs Manager

We are looking for a Senior Technical Regulatory Affairs Manager to join our team! The successful candidate will be responsible for writing, updating, and keeping track of regulatory documents, negotiating with stakeholders, and ensuring compliance with regulatory requirements.

Requirements

• University degree (Msc, PhD) in Pharmacy (Pharm D), Chemistry or biology, or alternative technical/science university degree
• Experience of at least 5 years in technical/CMC regulatory field or similar positions in the pharmaceutical industry
• Good organizational and communication skills
• Ability to proactively initiate and lead preparation of CMC documentation for filing activities
• Ability to manage multiple tasks with competing priorities
• Ability to manage complex projects
• Ability to communicate clearly and professionally both verbally and in writing
• Good MS Office, Veeva, DocuBridge skills
• Good spoken and excellent written English
• Knowledge of, and understanding of ICH guidelines (Quality), GMP requirements, Regulatory procedures (US-FDA, EU-CHMP, and others such as Health Canada, Swissmedic, Japanese PMDA, Chinese FDA)
• Advance knowledge of drug substance and/or Drug Product development, manufacturing process, quality control, packaging activities and regulatory environment