Regulatory Affairs Senior Specialist

The Regulatory Affairs Senior Specialist role will be responsible for life cycle management and regulatory filing maintenance activities, preparation and submission of regulatory documents, and providing regulatory guidance to other departments. The role will also involve preparing submission documentation for pharmaceutical products, monitoring the progress of regulatory submissions, and providing a critical review of technical documentation.

Requirements

• Strong knowledge of the Regional Pharmacopoeia (Ph. Eur. & USP), Title 21 of the Code of Federal Regulations and various Health Authority Guidances for Industry
• Knowledge of the regulatory process pertaining to drug development, registration, review and approval
• Experience in writing and submitting regulatory documentation
• Knowledge of cGMP awareness and compliance
• Excellent communication skills, both oral and written

Benefits

• Competitive salary
• Benefits
• Inclusive environment
• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension