Manager, Regulatory Affairs

Relevant experience in regulatory package preparation, compilation and submission to Health Authorities in various markets with focus on EU countries.

•Experience in CTRS filing is desired.• Working knowledge of EU regulatory procedures including adaptability to strict Health Authority and Sponsor timelines for completing submissions• Knowledge of EU country regulations• Able to contribute as local SME for countries and collaborate with global team and other stake holders for increasingly more complex regulatory submissions for Clinical Trial Applications.• Experience in handling health authority queries• Good understanding and knowledge of ICH guidelines and Ethics Committee requirements for Clinical Trial Applications in EU countries.• Clear oral and written communication skills• Acceptability towards varied cultural mindsets to collaborate efficiently with client counterparts and other internal stakeholders as well• Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.• Strong communications skills and ability to guide and mentor team members.• Ability to work in different time zones• Ability to work independently