Job Title: Regulatory Affairs Consultant
Location: Maidenhead
Contract: 12 months / hybrid 3 days onsite
Hours: 37.5 per week
Rates: £50-60p/h
Job Description
SRG are looking for a regulatory affairs consultant to join a leading pharmaceutical company based in maidenhead. As part of this role, you will be Supporting lifecycle management of applicable products or submissions, management of paediatric investigation plans and clinical trial activities with the Medicines and Healthcare Products Regulatory Agency (MHRA).
Duties and Responsibilities
Overall responsibilities
With supervision and guidance from Line Manager;
Acts as the primary Regulatory contact for identified portfolio.
Develops robust regulatory strategies and timelines for those products throughout their lifecycle and provides regulatory information updates to cross functional team.
Develops and maintains relationships with cross functional partners, as well as the Area Regulatory team to advocate the UK strategy objectives and timelines through the Area Regulatory Project Team.
Serves as Health Authority liaison and interface for Health Authority meetings to obtain optimal outcomes for patients and company portfolio.
Supports the business in planning for and execution of product launches, acquisitions and divestitures, as required.
Regulatory intelligence and external landscape monitoring - provides regulatory impact assessment and establishes best practice
Main Accountabilities
Supports Area and Brand teams as required to ensure local strategy is considered and that the key regulatory messaging is understood.
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 clinical trials, paediatric investigation plans, license lifecycle management
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.Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy