Director, Regulatory Affairs, EU Services

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Location: Central London / West End
Salary description: 60K

Our Client is a global leader in providing essential information to the world's businesses and professionals, Healthcare and Scientific Research. .

The Scientific business of Our Client provides information and knowledge to accelerate research, discovery and innovation. Their authoritative, accurate and timely information is essential for drug companies to discover new drugs and get them to market faster; researchers to find relevant papers and know what’s newly published in their subject; and businesses to optimize their intellectual property and find competitive intelligence.

Our Client has a product called Liquent, which is the global leader in providing regulatory software solutions, information products and related services for the life sciences industry. Liquent’s software and service offerings help to ensure that clients meet the strict standard of regulatory authorities across the world, helping them achieve quality, accuracy, and data integrity to deliver regulatory reports and submissions reliably and on time

Due to continued success Our Client has a new, exciting and challenging opportunity for a Director, EU Regulatory Services.

The Director, EU Regulatory Services will be expected to direct the EU Regulatory Services team and drive Liquent Direct Outsourcing sales in Europe working closely with the Sales Director, Europe to achieve targeted goals. The Liquent Direct services include submission outsourcing, project management, eCTD preparedness and education, submission publishing and submission publishing strategy. Responsibilities include revenue forecasting, EU sales support, customer presentations, management of European Regulatory Services revenue and career development for the EU Regulatory Services Team.

The ideal candidate will have the following:

•Bachelor’s degree or equivalent in life sciences or technology-related discipline.
•Significant pharmaceutical industry experience. End-to-end regulatory submission publishing and document management experience required with demonstrable management experience.
•Leadership, project management, and public speaking experience required.
•An understanding of global regulatory submission formats, industry standards, and guidelines, software validation concepts, and publishing best practices.
•An understanding of the Life Sciences Business, specifically in the pharmaceutical environment pertaining to regulatory guidance and regulatory submission assembly.
•Proficiency working in Microsoft Windows environment and with Windows-based applications including, but not limited to, Microsoft Office products, Adobe Acrobat, desktop publishing and graphics packages.
•Experience with publishing software ,InSight Publisher, CoreDossier and EZsubs as well as other Liquent products considered a plus.
•Strong organizational and interpersonal skills, this individual should be detail oriented with a strong customer service focus.
•Strong written and oral communication skills, including public speaking in formal and informal educational environments.
•The ability to work well independently and in a team environment.
•Ability to build strong relationships with global regulatory authorities.
•Management and supervisory experience.
•Familiarity with the audit process.

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