Regulatory Affairs Senior Manager required for a 12 month contract role with a leading multinational client based in Uxbridge or Cambridge.
This role will support one or more oncology products from a European regulatory perspective. As a member of the Global Regulatory Team (GRT), you will define the regulatory strategy and support the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.
Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within the client'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.
Leads development of regional regulatory documents and meetings in accordance with GRT strategy
Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals , compassionate use and paediatric 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.
Manages regional label negotiation activities
With minimal supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives
Co-ordinates company responses to requests from regulatory authorities, e.g Response to Questions (RTQs)
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)
Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to products.
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, current regulatory environment and competitor labelling
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
Manages core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy, includes contingency regulatory planning/risk assessment
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.
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.
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
Interested candidates should submit an updated CV
Please click the link below to apply, call Alba on (phone number removed) or alternatively send an up to date CV [Click here to apply]
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***
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