You will provide technological vision and leadership in the development and implementation of national systems and services to underpin the organisation and provide support to the management of health research and development. You will have a lead role in planning and implementing enterprise information systems to ensure more effective and integrated IT operations throughout the UK.

Candidates are likely to have a good IT/IS foundation within a major company managing and supporting large scale information systems and technology. They will have developed sizable teams and be able to demonstrate strong leadership skills within demanding IT environments, together with a track record of delivering systems and services that meet user requirements on time, within budget and to the highest of standards. Experience within the healthcare or health R&D environment would be useful but the ability to work strategically to deliver technology and information systems that support the business are essential. Qualifications: Good Honours Degree or equivalent.

Key responsibilities will include:

• Influence Key Opinion Leaders and policy makers to shape the UK environment in line with scientific evidence and business strategy relying on technical expertise and influencing skills
• To maintain and leverage effective relationships with R&D and ensure that UK influence is appropriately reflected in European plans
• To work closely with UK Clinical trials networks
• To provide leadership in meeting the requirements of the ABPI Code of Practice, all SOP's and GCP guidelines and their implementation
• Oversee Pharmacovigilance
• Handling related media issues in the medical or lay press in conjunction with Corporate Affairs.

• Medically registered in EU (applicable qualifications for GMC) with specific recognised expertise in Vaccines
• At least 5 years pharmaceutical industry experience, significant breadth of experience in both Medical Affairs and Clinical Research
• Ability to demonstrate experience of ABPI certification and Code of Practice appeals (or equivalent), successful Regulatory Authority interactions and Clinical Research strategy and operations
• Ability to work to SOP's and relevant statutory and regulatory requirements (e.g. Medicines Act, ABPI Code of Practice, ICH, EC Directives).

An immediate start is required, so a European passport is essential as there will not be any time to apply for visa, work/residence permits for this position.

You will develop a European regulatory business and subsequently manage a group of regulatory professionals and support staff. Provide strategic advice to clients on regulatory development of pharmaceuticals and biological products. In addition to expertise in regulatory strategy, procedures and submissions, experience of line management, staff development, global team working and financial procedures are desirable.

• Develop and lead the European Regulatory group
• Provide Regulatory Strategy advice
• Lead interactions with regulatory bodies in writing, at face-to-face meetings and on the telephone
• Direct preparation and submission of high quality documents on schedule and budget to EU regulatory bodies
• Business development
• Global team working
• Will be responsible for the overall management of Regulatory projects and will have the authority to make submissions to worldwide regulatory bodies
• Responsible for project costing, budget tracking and workload scheduling of Regulatory staff within the EU
• Responsible for approving timesheets and expenses of subordinate staff.

• Regulatory experience gained within a regulatory affairs function in the pharmaceutical, biotech or CRO industry or within a European regulatory body
• Ability to prepare and oversee preparation of regulatory documents
• Experience in the Pharmaceutical, biotechnology or life science industry
• Project experience (development of drug from pre-clinical, through early clinical trials for either a new drug or line extension)
• Experience of direct contact and negotiation with European regulatory authorities
• Line management experience
• Experience with US FDA and other regulatory agencies would be a benefit
• Interest in developing a regulatory consulting and submission business, organisation, marketing, client development and service provision
• Qualifications: Degree/PhD in life sciences.

Both OTC medicines and skincare are being targeted as major growth areas. Thus a position has been created to ensure the organisation remains at the forefront of global regulatory changes, across the product range, in order to develop new products. Reporting to the Director of Regulatory Affairs, you will provide European and global regulatory expertise across the product range.

In this highly visible role you will act as the company's authority on regulatory information, both internally and externally. You will work closely with internal technical experts, external authorities and trade associations to gather intelligence, which you will assess and disseminate throughout the organisation to support commercial objectives and aid in the development of new products. You will proactively lobby trade associations and stakeholders to influence legislation in-line with the company's interests.

This strategic position will have regulatory leadership for both European and global projects. You will manage regulatory activities to ensure project goals are met and provide critical regional area strategic guidance for development projects and marketed products. As global lead you will work closely with colleagues in the US and Japan to oversee development of on-going and proactive relationships with the regional regulatory authorities.

In this matrix role, you will demonstrate an in-depth understanding of current regulatory directives, the priorities of the regulatory bodies and their evolving objectives. Educated to degree level or above, the ideal candidate will have relevant regional regulatory affairs strategy experience and/or a successful track record in leading the submissions of new products. You will have proven ability to influence and negotiate at all levels combined with the confidence and knowledge to challenge colleagues appropriately.

• You will successfully implement Clinical Development plans within program budget and timelines. This includes the execution of planned Clinical Trials
• Ensure Medical Affairs works closely with Licensing, Business Development, R&D, QA, and Regulatory Affairs to provide timely and expert support to product development
• You will work closely with other Medical Affairs Departments, in order to come up with global clinical development plans and to maximize the value of new ideas.