Regulatory Affairs Senior Manager

Proclinical is seeking to hire a Regulatory Affairs Senior Manager. This role is on a contract basis and located in Uxbridge. This role will support one or more products from a regional regulatory perspective.

Job Responsibilities:

• Advising the GRT on regional considerations in developing strategy 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 Amgen'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) 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)
• 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 decisions
• Partner 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 Amgen 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's, current regulatory environment and competitor labelling Health Authority Interactions 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 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.

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.
• 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.

If you are having difficulty in applying or if you have any questions, please contact Athena Taylor Yan at +44 203 831 7658.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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