A leading pharmaceutical client is advertising a vacancy for a Senior CMC Reg Manager, based in their European office. The company's CMC team provides regulatory guidance to regulatory submissions across the EU, Switzerland, Balkans, Israel, and Russia.
This is an exciting opportunity to join a large pharmaceutical company and work with local and global regulatory teams.
Job Responsibilities :
Provide regional / country, product and regulatory expertise, and clarification on regional CMC RA requirements.
Review the preparation of M2 and 3 CMC components of filings.
Manage regional CMC filings from marketing authorisation
Author and coordinate responses to questions across assigned products and countries.
Project Manage submissions and monitor status of applications.
Ensure CMC regional issues impacting the global regulatory strategy for proposed CMC filings are considered.
Provide guidance for regulatory assessments of change control requests.
Skills and Requirements :
Direct experience with EU and EM market applications - MAAs or variations.
CMC regulatory knowledge & experience.
Strong record of related experience within Regulatory Affairs.
Experienced in creation and execution of regional regulatory strategies.
Current knowledge and application of CMC hot topics and knowledge of EU / EM legislation and guidance for biotechnology products.
Demonstrable multitasking, project management, and execution skills.
Good interpersonal skills, including communication, presentation, persuasion, and influence.
Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
Proficiency with computer skills, such as MS Office.