Senior Regulatory Manager

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

Senior Regulatory Manager- Pharmaceuticals - 12-Month Contract

Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Senior Regulatory Manager. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness.

Responsibilities

• Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for two or more products.
• Interfaces with the affiliate offices for specific strategies or activities that impact a specific country.
• Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies.
• Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries.
• Manages strategy and execution for all regulatory CMC submissions (e.g. late stage clinical trials, variations, extensions and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
• Authoring and coordinating responses to questions across assigned products and countries.
• Communicate regional needs for ensuring reliability of the supply chain and successful launch are well defined and implemented in collaboration with relevant regional stakeholders.
• Provides guidance for regulatory assessments of change control request.
• Sets project time frames and priorities for products under their responsibility based on project objectives and ongoing assignments; raises resource constraints.
• Gathering, consolidating and analysing regulatory intelligence for International Markets and supports its application to product-specific activities.
• Share regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerations.
• Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to the company’s products.

If this role is of interest to you, please apply now!