Regional Regulatory Hub Strategist

Proclinical Staffing; Greater London; On-site; GBP 50,000 - 80,000

Job description

Proclinical is seeking a Regional Regulatory Hub Strategist to support regulatory CMC submissions, ensuring compliance with local regulations across various markets. The role focuses on complex site transfers and multi-market projects, requiring effective communication and strategic planning to meet global supply and commercial objectives.

Responsibilities:

• Support regulatory CMC submissions for country acceptability and manage HA queries.
• Focus on complex site transfers, legal entity name changes, and multi-market projects.
• Ensure transparency and excellence in regulatory strategy execution.
• Build cross-functional relationships and communicate regulatory timelines and strategies.
• Produce and dispatch dossiers according to defined filing plans.
• Manage regulatory activities and drive timely issue resolution.
• Collaborate on post-approval strategy and execution.
• Provide input on technical issues and ensure submission readiness.
• Author local submission components as needed.
• Coordinate with global strategists on regulatory queries.
• Cultivate positive professional relationships and hold accountability for results.

Key Skills and Requirements:

• Bachelor's degree in Chemistry, Pharmacy, or related life science; advanced degrees are advantageous.
• Understanding of IDM regulatory environment (EU, UK, CH, EME, ANZ, Canada, Korea).
• Expertise in managing complex site transfers.
• Competence in CMC submissions and regulatory risk identification.
• Knowledge of drug development practices and regulations.
• Strategic, analytical thinking, and strong communication skills.
• Teamwork and collaboration abilities.
• Quality and compliance orientation.
• Fluent in English, both written and spoken.
• Experience in pharmaceutical regulatory affairs or compliance.