Regulatory Affairs Senior Manager(support one or more oncology products)

Job Description

Title: Regulatory Affairs Senior ManagerDuration: 12 MonthsLocation: Uxbridge or CambridgeThis 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.The purpose of this role is: To ensure that Client acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as to market approved medicinal productsTo ensure timely regulatory compliance with above approvals, As requested this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade)This role is responsible for:Advising the GRT on regional considerations in developing strategyEnsuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholdersMay manage one or more regional leads or support rolesStrategy and Execution Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within Clients 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 strategyProvides 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.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 objectivesCo-ordinates company responses to requests from regulatory authorities, e.g Response to Questions (RTQs) 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 ManagementDevelop predictions for expectations and risks associated with outcomes by regulatory agenciesEnsure regulatory product compliance for product (e.g. IMR, PMCs, paediatric and other agency commitments) Collaboration Share regulatory information and implications with the GRT colleagues on an ongoing basis and provide advice on regional considerations Communicate and ensure alignment of regional management before GRT strategy decisionsPartner with regional management and peers to ensure consistency in procedures and agency interactions Regulatory Research Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Client 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, guidances, current regulatory environment and competitor labelling Health Authority InteractionsAct as contact and create relationships with agency staff on specific product assignmentDocument and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. managementManages core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategyincludes 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 engagementProvides managerial leadership & direction to assigned team allowing appropriate prioritization of resources to achieve goals. Knowledge and Skills 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 processesAbility 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. Required skills

regulatory compliance

oncology products

define the regulatory strategy and support the desired labelling

maintains all the required licenses in order to support clinical trial

Keyskills :
regulaty compliance oncology products define the regulaty strategy and suppt the desired labelling maintains all the required licenses in der to suppt clinical trial