Junior Regulatory Affairs Scientist

Description:

Thornshaw Scientific, in collaboration with my client, a global pharmaceutical company, now have a new opportunity for an RA Scientist to join the Dublin team.

The main purpose of this position is supporting and leading the in the implementation and maintenance of the Regulatory Information Management (RIM) system into their global organisation.

My client is investing in a new digital platform RIM tool for management and sharing of global regulatory information. The RIM system will contain documents such as; marketing authorisation registration dossiers containing registered information on the safety, quality and efficacy on their medicinal products and life-cycle maintenance registration information.

To be considered for this new opportunity you need to meet the following criteria:
 

• > 3 years pharmaceutical regulatory experience,
• RIM experience of pharmaceutical data management, data migration and e-platforms
• Proven experience of regulatory submissions (MAAs and LCM)
• Compliance with SOPs, Change controls and regulatory best practices
• Publishing: eCTD Office and or NEES – an advantage
• Effective teamwork track record
• IT Literate and working familiarity with regulatory publishing platforms
• Project management and reporting experience