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:
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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
requirements.
Maintain high quality standards and strive for continuous improvement, and have an innovative
approach in responding to the evolving regulatory environment.
Have xperience in primarily the European medical device regulatory field dealing with at least
Class I and II devices (Technical Documentation preparation, dealing with Notfied Body for audits,
inspections and queries, Change Controls and Lifecycle regulatory activities for medical devices,
relevant ISO standards and EU regulatory Directives and Guidance).
Have familiarity with with orally administered devices
Duties & responsibilities:
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Responsible for ensuring preparation of high quality documentation for all regulatory submissions,
both medicinal products and devices, with minimum supervision; liaising with relevant
departments to ensure regulatory requirements for these submissions are met; proactively
communicating with regulatory authorities and notified bodies in order to expedite approval of
these submissions.
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
To anticipate and resolve complex regulatory issues
To actively participate as primary regulatory resource in cross-functional project teams
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
Records Retention procedures.
Individual requirements:
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Considerable regulatory experience and general knowledge of EU regulatory requirements
(including GMP, GLP and GCP)
Proven experience in the product registration and life cycle maintenance of medical devices and
medicinal products
Understanding of legislation and directives
A full strategic understanding of medical device and drug development principles and processes
Awareness, understanding and an ability to interpret the local guidelines relevant to his/her
technical/functional responsibilities, specifically those related to developing a Target Product
Profile and delivering a product at the end of the development process
Demonstrates an ability to analyse and summarise data to a high level
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.
Human Resources
Last Updated 11/06/2014