3 Days Left Regulatory Affairs Executive
Job Summary
We are seeking a Regulatory Affairs Specialist to manage the full life cycle of regulatory submissions for Emerging and Regulated markets. The ideal candidate will have in-depth knowledge of regulatory submission processes and life cycle management, with excellent written and verbal communication skills.
Key Responsibilities:
• Manage pre- and post-approval processes, including initial submissions, query responses, variations, renewals, and post-approval maintenance.
• Prepare, compile, and submit high-quality regulatory dossiers that meet country-specific requirements.
• Address regulatory queries swiftly and accurately, ensuring timely communication and resolution without delays.
• Serve as the sole regulatory point of contact within cross-functional teams.
• Review technical data and ensure alignment with updated regulatory requirements.
• Maintain accurate and comprehensive documentation of regulatory activities.
• Stay current with changes in regulatory policies, guidelines, and processes.
Requirements:
• M. Pharma with 2-5 years of relevant experience in Regulatory Affairs.
• In-depth knowledge of regulatory submission processes and life cycle management.
• A proactive, detail-oriented approach with the ability to independently manage multiple projects and deadlines.
• Excellent written and verbal communication skills.
Apply Now
We are seeking a Regulatory Affairs Specialist to manage the full life cycle of regulatory submissions for Emerging and Regulated markets. The ideal candidate will have in-depth knowledge of regulatory submission processes and life cycle management, with excellent written and verbal communication skills.
Key Responsibilities:
• Manage pre- and post-approval processes, including initial submissions, query responses, variations, renewals, and post-approval maintenance.
• Prepare, compile, and submit high-quality regulatory dossiers that meet country-specific requirements.
• Address regulatory queries swiftly and accurately, ensuring timely communication and resolution without delays.
• Serve as the sole regulatory point of contact within cross-functional teams.
• Review technical data and ensure alignment with updated regulatory requirements.
• Maintain accurate and comprehensive documentation of regulatory activities.
• Stay current with changes in regulatory policies, guidelines, and processes.
Requirements:
• M. Pharma with 2-5 years of relevant experience in Regulatory Affairs.
• In-depth knowledge of regulatory submission processes and life cycle management.
• A proactive, detail-oriented approach with the ability to independently manage multiple projects and deadlines.
• Excellent written and verbal communication skills.