Sr Manager Regulatory Affairs

Position: Sr Manager Regulatory Affairs
Work Structure: Monday - Friday, 39 hours per week
Pay Rate: £58 - £64/hour (Inside IR35)

Job Description:

We are seeking a seasoned Sr. Manager of Regulatory Affairs to support one or more products from a regional regulatory perspective. As an integral member of the Global Regulatory Team (GRT), you will develop and execute regional regulatory strategies to achieve desired labelling and manage effective agency interactions.

Key Responsibilities:

• Strategic Guidance: Advise the GRT on regional considerations to ensure regional needs are defined and implemented in collaboration with relevant stakeholders.
• Management: Potentially supervise one or more regional regulatory leads or support staff.
• Regulatory Submissions: Plan and manage regulatory submissions for clinical trial and marketing applications in compliance with global filing plans and local regulatory requirements.
• Regulatory Strategy Implementation: Implement product-related regulatory strategies, processes, and activity planning in accordance with national legislation and regulatory requirements.
• Documentation and Meetings: Lead the development of regional regulatory documents and meetings aligned with GRT strategy.
• Product Development Optimisation: Provide regulatory direction on regional mechanisms to optimise product development, including expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use, and pediatric plans.
• Label Development and Negotiation: Direct the development of the regional product label, collaborate with the Labelling Working Group, and manage regional label negotiation activities with minimal supervision.
• Regulatory Compliance and Communication
• Risk Management: Estimate the likelihood of regulatory success, develop predictions for regulatory agency outcomes, and advise on regulatory implications related to global clinical development plans.
• Collaboration and Alignment
• Regulatory Research and Awareness: Maintain awareness of new and developing legislation, regulatory policy, and technical guidance. Perform regulatory research to support regional product advancement and evaluate the impact of regional regulations and competitor labelling.

Qualifications:

• Extensive regulatory knowledge in regional legislation.
• Experience working with policies, procedures, and SOPs related to medicinal products.
• Understanding of regional regulatory procedures for CTAs, MAs, post-approval changes, extensions, and renewals.
• Strong knowledge of drug development and the regional regulatory environment in relevant product areas and development stages.
• Proven ability to resolve conflicts and develop beneficial outcomes.
• Cultural awareness and sensitivity to achieve results across regional and international borders.
• Excellent communication and managerial skills to lead and direct an assigned team effectively.

Knowledge and Skills:

• Comprehensive understanding of regulatory activities and their impact on projects and processes.
• Ability to prioritise resources to achieve goals and provide managerial leadership and direction.
• Experience in conducting regulatory research and maintaining awareness of regulatory changes and competitor activities.
• Strong scientific and technical excellence in the regulatory environment.

How to Apply:

Please submit your resume and a cover letter outlining your qualifications and experience relevant to this role.

We look forward to hearing from you!

If you possess the expertise and qualities required for this challenging yet rewarding role, please submit your application including your CV to jkirlew@i-pharmconsulting.com or press the apply button below!

Please note: You must be able to work or the UK without restriction or sponsorship to be eligible for this role.If you are interested in finding out more about this role or others, please contact Jada Kirlew at jkirlew@i-pharmconsulting.com or call: +44 (0)20 7551 0727