Job Title: Regulatory Affairs Manager
Location: Maidenhead
Contract: 12 months / hybrid 3 days onsite
Hours: 37.5 per week
Rates: £80-90p/h
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
Effective project management experience
Consultative and collaborative interpersonal style
Excellent English language skills
The ability to thrive in a changing environment and to re-prioritise workload to meet business needs.
