Senior Regulatory Manager - Global Submissions Lead

Quanta part of QCS Staffing; England; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading biotechnology firm in the UK is seeking a Senior Regulatory Manager on a 12-month contract. This role involves generating country-specific regulatory strategies, managing CMC submissions, and ensuring compliance with local requirements. Ideal candidates should have experience in regulatory strategy and the ability to communicate effectively with stakeholders for successful product launches.

Qualifications

• Experience in generating country specific regulatory strategies.
• Ability to provide feedback regarding submission plans.
• Understanding of CMC filings and regulatory compliance.

Responsibilities

• Generate country specific regulatory strategies for products.
• Interface with affiliate offices for country-specific strategies.
• Ensure CMC regional issues are considered for global strategy.
• Review M2 and 3 CMC components for submission fitness.
• Manage strategy for all regulatory CMC submissions.
• Author and coordinate responses to regulatory questions.
• Communicate supply chain needs with regional stakeholders.
• Provide guidance for change control requests.
• Set time frames and priorities for product responsibilities.
• Gather and analyze regulatory intelligence for markets.
• Share regulatory information and advice with stakeholders.
• Maintain awareness of legislation and regulatory guidance.

Job description

A leading biotechnology firm in the UK is seeking a Senior Regulatory Manager on a 12-month contract. This role involves generating country-specific regulatory strategies, managing CMC submissions, and ensuring compliance with local requirements. Ideal candidates should have experience in regulatory strategy and the ability to communicate effectively with stakeholders for successful product launches.