Regulatory Affairs Specialist

Job Description

Job Description:

The role is accountable for undertaking a variety of regulatory activities, under supervision, across a range of products and licensing routes for the UK market including:

• Developing regulatory strategy and contribute to regulatory filing activities and documentation (including scientific advice and paediatric investigational plans or orphan designation), for new marketing authorisation (MA) applications and product launches. Ensures regulatory strategies are aligned with local business objectives and deliverables.
• Ensures life-cycle maintenance of assigned, authorised products, through timely submission of variations, renewal applications, line extensions and notifications.
• Liaising and negotiating with the MHRA.
• Implementation and communication of MA changes across stakeholder groups. Ensuring all compliance activities are correctly managed.
• Generation and maintenance of prescribing information, patient information leaflets and packaging components, including artwork management, and ensuring regulatory compliance with legislation and company approval systems.
• Developing and maintaining a sound knowledge of UK regulatory legislation and guidelines to provide advice and expertise internally for matters related to our products.
• Representation of regulatory affairs at cross functional meetings including, new product launches, product acquisitions and ad-hoc product issues.
• Maintaining a positive relationship with internal and external regulatory contacts.
• Utilising and maintaining company compliance systems in relation to product portfolio and meeting compliance expectations.
• Working as a strong member of the UK regulatory team, contributing to departmental meetings, ad-hoc projects and issues.

Qualifications:

BSc. Degree or higher (or equivalent qualifications) in pharmacy or a life-science subject.

Skills/Knowledge:

• Some exposure to a regulatory affairs department would be an advantage but not essential. Experience in the pharmaceutical industry is preferable, in regulatory, medical or laboratory position.
• Ability to communicate well verbally and in writing is essential.
• Excellent organisational and planning skills.
• Meticulous attention to detail.
• Be flexible enough to successfully handle conflicting time pressures and a large volume of work.
• Must be able to work both alone and as part of a team and take responsibility for managing the day-to-day regulatory activities for a portfolio of products.
• Work effectively within the Regulatory Affairs team and with other stakeholders to deliver on Company Objectives and Goals.
• Able to demonstrate a genuine interest and knowledge of the regulatory environment and a desire to succeed in a regulatory affairs role in the pharmaceutical industry.
• Ability to identify compliance risks and escalate when necessary.