Regulatory Affairs Manager

JR United Kingdom; Maidenhead; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company based in Maidenhead is seeking a Regulatory Affairs Manager for a 12-month hybrid contract. In this role, you will provide regulatory strategy direction and collaborate with global teams to align with business objectives, specifically focusing on product development and compliance within the UK market.

Qualifications

• Varied experience within UK or EU Regulatory Affairs including development strategies.
• Knowledge in specific therapeutic areas, especially Oncology.
• Ability to adapt in a changing environment and re-prioritize workload.

Responsibilities

• Define, lead, and conduct UK MAA and product lifecycle filing strategies.
• Act as project lead for MHRA submission activities and ensure compliance.
• Build relationships with key internal stakeholders to facilitate collaboration.

Skills

Excellent verbal and written communication skills

Strong influencing skills

Collaborative interpersonal style

Education

Life Sciences Degree or equivalent experience

Job description

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Contract: 12 months / hybrid 3 days onsite

Job Description

SRG is seeking a Regulatory Affairs Manager to join a leading pharmaceutical company based in Maidenhead. In this role, you will provide UK regulatory strategy recommendations to Area/Global teams to support global product development for new and existing products, aligned with business objectives.

You will support global product development strategies, outline options for UK Scientific Advice/PIP/IMPD, coordinate the preparation of briefing packages, and more.

Duties and Responsibilities

• Define, lead, and conduct UK MAA, new indications (National, IRP), and product lifecycle filing strategies, identifying risks and proposing mitigations.
• Act as project lead for MHRA submission activities: clinical trials, paediatric investigation plans, lifecycle management of licensed and unlicensed products.
• Collaborate with the Europe region Regulatory team to advocate for the affiliate's strategy objectives and timelines.
• Serve as Health Authority liaison and interface with UK Health Authority meetings to achieve optimal outcomes for patients and the company's portfolio.
• Ensure compliance within the regulatory department and collaborate with internal stakeholders to meet statutory, quality, and business requirements.
• Perform quality control checks on staff dossiers prior to MHRA submission.
• Conduct impact assessments for regulatory updates.
• Plan, track, and archive activities effectively, especially submissions, internal memos, and key correspondence, using RIM system.

Main Accountabilities

• Develop and execute regulatory strategies for new MAA or indications in collaboration with UK Therapy Area Heads and the Europe region Regulatory team.
• Ensure timely submission of MHRA applications in accordance with requirements.
• Communicate regulatory and safety information promptly, complying with regulations and company policies.
• Stay updated on regulatory issues and proactively resolve regulatory challenges within the UK, escalating to the Director, Regulatory Affairs as needed.
• Build relationships with key internal stakeholders to facilitate cross-functional collaboration.
• Keep abreast of regulatory intelligence and implement necessary legislative changes proactively.

Experience and Qualifications

• Life Sciences Degree or equivalent experience.
• Varied experience within UK or EU Regulatory Affairs, including development strategies, new MAA/Indications, clinical trials, paediatric investigation plans, and license lifecycle management.
• Knowledge in specific therapeutic areas, especially Oncology.
• Excellent verbal and written communication skills.
• Strong influencing, tactical, and presentation skills.
• Collaborative interpersonal style.
• Ability to adapt in a changing environment and re-prioritize workload to meet business needs.