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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.
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