Regulatory Affairs

• Experience:
• Total of 10 to 15 years in Regulatory Affairs (RA).
• At least 6 years of experience in regulated markets such as the USA, EU, UK, or CA.
• Multiple market experience is an advantage.
• Skills:
• Excellent written and verbal English communication skills.
• Proven team handling experience.
• Familiarity with eCTD submissions.

Job Profile:

• Act as a regulatory lead.
• Responsible for the execution and delivery of all RA projects.
• Assist in and perform dossier drafting and compilation for all markets.
• Perform quality checks on all output from the RA team.
• Responsible for all regulatory submissions from the RA team.
• Represent project status to the client and the RA Head of Department (HOD).
• Mentor less experienced or new staff members.

Past Experience:

• Required to have 6+ years of experience in regulatory market (USA/EU/CA/UK) dossier submission.