Principle Regulatory Affairs Executive You will be part of a very

Principle Regulatory Affairs Executive
You will be part of a very experienced pan-European team, where we believe our skills, experience
and resources can improve patients’ lives. Collaboration is a way of life for us. As One Norgine, we
are dedicated to working with each other and with our stakeholders. Inventiveness, flexibility and
teamwork are at the heart of what we do. It’s what makes us different.
The successful candidate for this role will:
Have worked with minimum supervision and be able to understand, interpret and advise on
regulations, guidelines, procedures and policies relating to life cycle teams, to expedite regulatory
submissions, review and approval of medicinal licence maintenance activities.
Have a successful track record of delivering dossiers that comply with global regulatory
Maintain high quality standards and strive for continuous improvement, and have an innovative
approach in responding to the evolving regulatory environment.
Duties & responsibilities:
To prepare and collate high quality documentation for all regulatory submissions.
To liaise with relevant internal departments and external contacts to ensure regulatory
requirements for these submissions are met and to proactively communicate with regulatory
authorities in order to expedite approval of submissions.
To provide regulatory advice and support to other areas of the Company and be the primary
regulatory resource in cross-functional project teams.
To anticipate and resolve complex regulatory issues.
To prepare and review plans for submissions within agreed timelines and ensuring alignment with
agreed strategy.
To identify and provide information for incorporation in the Regulatory databases as appropriate
To provide input into the budgeting process; this may include information relating to regulatory
fees required for prospective regulatory submissions.
To maintain the paper and electronic filing systems for assigned products/countries, following
internal procedures.
Individual requirements:
Considerable EU regulatory experience and general knowledge of global regulatory requirements
(including GMP, GLP, GCP and GDP).
Expertise in the registration and maintenance of medicinal products. With a full strategic
understanding of the drug development principles and processes. A good understanding of the
CMC aspects of a dossier would be expected.
Awareness, understanding and an ability to interpret the local guidelines relevant to his/her
technical/functional responsibilities with proven experience in the life cycle maintenance of
medicinal products – with a demonstrable ability to analyse and summarise data to a high
Be comfortable working in cross-functional project teams, have excellent interpersonal skills, with
a strong compliment of verbal and written communication, on top of effective influencing skills.
Thank you for your interest in Norgine. Please submit your application to
alternatively please forward your completed application to:
Human Resources Department, Norgine House, Widewater Place, Harefield, UB9 6NS.
Human Resources
Last Updated 11/06/2014