Senior Regulatory Affairs Manager

Proclinical is currently recruiting for a Senior Regulatory Affairs Manager job at a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. They are seeking an individual to bring solid regulatory affairs experience their team at their offices in Cambridge. This is an exciting opportunity to work for one of the world's biggest biotechnology firms that employs over 17,000 staff globally.

This role will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), they will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions. To ensure that the company acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products. To ensure regulatory compliance, with a focus on patient safety. 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).

Job Responsibilties:

• 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.
• 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, Fast Track, 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
• Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including 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 company 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 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

Skills and Requirements:

• Regulatory knowledge in national regulations
• Working with policies, procedures and SOP's
• Experience with national legislation and regulations relating to medicinal products
• Understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.
• Understanding of drug development
• Team work
• Negotiation skills
• Good communication skills - both oral and written
• Ability to understand and communicate scientific/clinical information
• Ability to anticipate and prevent potential issues
• Communication of regulatory strategies such that expectations are understood.
• Anticipate regulatory agency responses to strategy
• 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

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call David Nixon on +44 203 078 9544 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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