Manager. Regulatory Policy
4 weeks ago
Position: Sr Manager Regulatory Affairs
Monday - Friday, 39 hours per week
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.
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.
Provide regulatory direction on regional mechanisms to optimise product development, including expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use, and pediatric plans.
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.
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.
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.
Comprehensive understanding of regulatory activities and their impact on projects and processes.
Experience in conducting regulatory research and maintaining awareness of regulatory changes and competitor activities.
Strong scientific and technical excellence in the regulatory environment.
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.
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