UK, Ireland & Malta Regulatory Affairs Product Specialist

Nicholas Howard Ltd
London (Greater)
02 Dec 2017
05 Jan 2018
Contract Type
Full Time
Nicholas Howard Limited are delighted to be recruiting for a new and exciting role as a Regulatory Affairs Product Specialist.

Based in London, the successful candidate will provide regulatory strategic support for the product portfolio within the local business/operating company (LOC). Primary responsibilities include operational regulatory affairs activities, involving interface from LOC to European and Global RA, ensuring conformance to national and EU Drug Laws, maintaining labelling information to internal and external partners, communicating with regulatory authority and regulatory institutions if required in collaboration with EU strategists, supporting internal Global RA, other R&D departments and providing collaborative support for commercial teams. Approval of specific advertising and promotional materials in accordance with UK/IE national legislation and codes of practice. Responsibilities include ensuring adherence to company standards and local laws.

Education & Experience:

- BSc/MSc in a scientific discipline preferred.
- Minimum 5 years of experience with multinational companies in regulatory affairs preferred.
- Proven experience and relationship with UK or Ireland Regulatory Authorities.
- Demonstrable experience with advertising and promotional materials review in accordance with UK/IE national legislation and codes of practice.
- Strong judgment and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies.
- Ability to challenge self and others to overcome barriers and deliver high quality solutions to the business.
- Effectively embraces change and is able to flourish in a global structure, aligning people and processes to deliver excellence.
- Creates an open collaborative environment of continuous improvement within LOC stakeholders and Global functions.
- Demonstrated ability to assess the internal and external environment to recommend appropriate risk-taking.
- Incumbents at this level are involved in a variety of diverse scope and complexity of projects which require strategic thinking and thorough and practical solutions.
- Ability to handle multiple tasks and work under pressure.
- Highly organized.

To be considered for this position please apply below.