Regulatory Affairs Manager
16 Days Old
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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.
- Location:
- Maidenhead, England, United Kingdom
- Salary:
- £125,000 - £150,000
- Category:
- Management & Operations
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