JOB DESCRIPTION Principle Regulatory Affairs Executive – (11

Principle Regulatory Affairs Executive – (11 month fixed term contract)
You will be part of an experienced global regulatory team. As One Norgine, we are dedicated
to working in a solution drive manner, developing strategic and innovative ideas to resolve
complex issues.
About the company
Founded in 1906, Norgine is an independent European specialty pharmaceutical company.
We are focused on the development, manufacturing and marketing of medicines for important
areas of healthcare, where we believe our skills, experience and resources can improve
patients’ lives – we focus on three core areas gastroenterology, hepatology, critical and
supportive care. 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 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 and
filing systems as appropriate and in line with company procedures.
 To provide input into the budgeting process; this may include information relating to
regulatory fees required for prospective regulatory submissions.
Individual requirements:
 Considerable EU regulatory experience and general knowledge of global regulatory
requirements (including GMP, GLP, GCP and GDP). International regulatory experience
would also be of benefit.
 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 standard.
Norgine Limited
Norgine House, Widewater Place, Moorhall Road,
Harefield, Uxbridge UB9 6NS,UK
Tel: +44 (0)1895 826600 Fax: +44 (0)1895 825865
Be comfortable working and contributing in cross-functional project teams, have excellent
interpersonal skills, with a strong compliment of verbal and written communication, on top
of effective influencing skills.
Please forward your CV and cover letter to Conor Pillai – in the HR