Senior Regulatory Affairs Manager- Development- UK – 12 Months contract - home based
We have an exciting opportunity available for a global biotech company with excellent development pipeline to support projects in development stage.
Advising in developing strategy for regional needs and collaboration with relevant 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 in compliance with global filing plans and local regulatory requirements. Implements product related regulatory strategies,
Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals , compassionate use and pediatric plan)
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.
Communicates regulatory strategies as appropriate such that expectations are understood. Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line Management
Develop predictions for expectations and risks associated with outcomes by regulatory agencies Ensure regulatory product compliance for product (e.g. IMR, PMCs, paediatric and other agency commitments)
Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. Evaluates and communicate impact of relevant regional regulations, guidance’s, current regulatory environment and competitor labelling Health Authority Interactions Act as contact and create relationships with agency staff on specific product assignment
Manages core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy includes contingency regulatory planning/risk assessment Management Supports communication/collaboration between direct reports who are regional leads and regional head for program issues requiring next level engagement
Provides managerial leadership & direction to assigned team allowing appropriate prioritization of resources to achieve goals.
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.
Understanding of drug development Scientific / Technical Excellence
Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
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.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.