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Contract: 12 months / hybrid 3 days onsite

Job Description

SRG are looking for a regulatory affairs manager to join a leading pharmaceutical company based in maidenhead. As part of this role, you will be providing UK regulatory strategy recommendations to Area/Global teams to shape the global product development for new and existing products in line with business objectives.

As well as supporting global product development strategy(s); outlining options for UK Scientific Advice/PIP/IMPD, coordinating preparation of briefing packages and much more.

Duties and Responsibilities

• Define, lead & conduct UK MAA, new indications (National, IRP) and product lifecycle (if appropriate) filing strategy(s), identifying risks and proposing mitigation.
• Act as project lead to build and execute MHRA submission activities: clinical trials, paediatric investigation plans, lifecycle management of licensed and/or unlicensed products
• Works with the Europe region Regulatory team to advocate for the affiliate's strategy objectives and timelines
• Serves as Health Authority liaison and interfaces with UK Health Authority for meetings to obtain optimal outcomes for patients and the company’s portfolio
• Ensures compliance within the regulatory department and collaborates with internal stakeholders, as appropriate, to ensure compliance with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of the company
• Quality control check members of staff’s dossier prior to MHRA submission
• Conduct impact assessment per regulatory updates
• Responsible for ensuring effective planning, tracking, archiving of activities, especially submissions, internal memos and key correspondence. Ensures effective planning and tracking of activities via RIM system

Main Accountabilities

• Develop & execute in association with UK Therapy Area Head (s) Europe region Regulatory team regulatory strategies for new MAA or indications
• 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 operate 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 escalate 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.

Experience and Qualifications

• Life Sciences Degree or equivalent experience
• Varied experience within UK or EU Regulatory Affairs, including development strategy, new MAA/Indications, clinical trials, paediatric investigation plans, license lifecycle management
• Knowledge in specific therapeutic areas – Oncology
• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal and Analyst

• Industries

  Pharmaceutical Manufacturing

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