Regulatory Affairs Senior Manager
A large biopharmaceutical company are looking for a talented Regulatory Affairs Senior Manager to join their team in Cambridge. This organisation is known for their extensive experience in discovering, developing and manufacturing innovative human therapeutics.
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
- May manage one or more regional leads or support roles
- Strategy and Execution Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within the company's portfolio in compliance with global filing plans and local regulatory requirements.
- Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Directs the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Regulatory Research Maintains an awareness of new and developing legislation, regulatory policy and technical
- Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
- Act as contact and create relationships with agency staff on specific product assignment
- Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management
- Provides managerial leadership & direction to assigned team allowing appropriate prioritization of resources to achieve goals.
Skills and Requirements
- Regulatory knowledge in regional legislation Working with policies, procedures and SOPs
- Experience with national legislation and regulations relating to medicinal products
- Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
- Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across both regional country and International borders.
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall on 44 203 0789 542 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.