Regulatory Affairs Consultant

Job Description:

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