Regulatory Affairs Consultant

Contract: 12 months / hybrid 3 days onsite

SRG are looking for a regulatory affairs consultant to join a leading pharmaceutical company based in Maidenhead. As part of this role, you will be supporting lifecycle management of applicable products or submissions, management of paediatric investigation plans and clinical trial activities with the Medicines and Healthcare Products Regulatory Agency (MHRA).

Overall responsibilities

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• Acts as the primary Regulatory contact for identified portfolio.
  
• Develops robust regulatory strategies and timelines for those products throughout their lifecycle and provides regulatory information updates to cross functional team.
  
• Develops and maintains relationships with cross functional partners, as well as the Area Regulatory team to advocate the UK strategy objectives and timelines through the Area Regulatory Project Team.
  
• Serves as Health Authority liaison and interface for Health Authority meetings to obtain optimal outcomes for patients and company portfolio.
  
• Supports the business in planning for and execution of product launches, acquisitions and divestitures, as required.
  
• Regulatory intelligence and external landscape monitoring – provides regulatory impact assessment and establishes best practice
  

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• Supports Area and Brand teams as required to ensure local strategy is considered and that the key regulatory messaging is understood.
  
• Ensures submission and content of MHRA new and product lifecycle applications are made in accordance with appropriate timings and requirements.
  
• Ensures appropriate and timely communication of regulatory and safety information as required by local regulation, company policies and procedures.
  
• Keeps up to date with all appropriate Regulatory issues and operates as a ‘problem-solver’, to provide effective resolution of regulatory issues occurring within the UK, with an appreciation of business needs and priorities and will elevate to the Director, Regulatory Affairs as necessary.
  
• Builds business relationships with key internal stakeholders, including Europe region Regulatory Affairs, Medical Affairs, Market Access, Commercial and QA, as required to enable good cross‑functional working.
  
• Stays abreast of all Regulatory intelligence updates and is proactive regarding implementation of necessary legislation/regulation changes.
  

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• Life Sciences Degree or equivalent experience.
  
• Varied experience within UK or EU Regulatory Affairs, including clinical trials, paediatric investigation plans, license lifecycle management.
  
• Excellent communication skills, both verbal and written.
  
• Effective influencing, tactical and presentation skills.
  
• Consultative and collaborative interpersonal style.
  
• The ability to thrive in a changing environment and to re‑prioritise workload to meet business needs.