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Regulatory Manager, Contract, Post Marketing

Employer
NonStop Consulting
Location
Edinburgh
Salary
COMPETITIVE RATE
Closing date
Apr 19, 2018

View more

Sector
Pharmaceutical, Regulatory Affairs
Contract Type
Contract/Freelance
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional

Job Details

Regulatory Manager, Contract, Post Marketing, Rare Diseases

While recruiting for a permanent position we are searching for a contractor in the interim. The contract would be for initial three months with opportunity to roll on. For this role we do need candidates with post marketing regulatory experience within orphan or rare disease products. You also need to be available immediately on a full time basis.

Due to a new product in their portfolio this biotechnology company is looking for an experienced regulatory professional to join the team. They have a strong portfolio within several therapy areas, mainly rare diseases and always investing in development. One of the key parts of this role will be producing regulatory documents for submission.

Within this role you will be working on producing documents such as:

Ensuring all Marketing Authorisations, they are responsible for, are kept up to date to allow continued commercialisation by ensuring variation and license renewals applications are submitted in accordance with accepted regulatory standards and within appropriate time frames.
Ensure timely response to all enquiries into Regulatory Affairs (internal and external).
Contribute to maintenance of various forms of labelling, e.g. basic product information, patient information leaflets, labelling texts and artwork.
For this role you do need to have strong regulatory experience in the pharmaceutical/biotech industry and experience with submissions for the UK and EU.

For this role we do need candidates with experience in post marketing work for orphan/rare disease products.

If this role is of interest to you then do not hesitate to get in contact today as my client is looking to select suitable CV's in the next week. Please send your CV in MS Word format (I am unable to accept PDF copies!) to me directly, Andrew Dixon, at a.dixon@nonstop-pharma.com, or by calling me on +44 207 940 2105 for a discussion in confidence.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

What I offer: As a specialist Headhunter for the healthcare industry I can offer: market knowledge and a personal service, therefore not just finding you suitable roles but in addition to this offering accurate and honest advice about salaries, work conditions and department reputations for positions across the UK and the EU.

regulatory writing, contract, consultant, regulatory, submissions, UK, England, Scotland, Edinburgh, Pharma, Biotech, biologics, development, EU, market authorisations, MAA, market applications, new product submissions, dossiers, Bio-tech,

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
Website

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