Regulatory Affairs Manager - Pharmaceuticals

Gold Group Ltd

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Company Type :

Staffing Firms

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Address 1 :

United Kingdom,Wrexham,Wrexham,

Key Skills :

regulatory affairs manager generics otc maa submissions leadership global

Salary :

£40000 - £47000 per annum + bonus + benefits

Date Posted :

26 May, 2016

Company Name :

Gold Group Ltd

Location1 :


Job Category :

Regulatory Affairs Jobs

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Job Title:Regulatory Affairs Manager - Pharmaceuticals
Pay:£40,000 - £47,000 + company bonus + benefits
Job Type:Permanent, Full Time, Office based
Company:Gold Group Ltd - client to be discussed upon application

Regulatory Affairs Manager - Pharmaceutical


My client is a highly regarded and well known Global Generic Pharmaceutical company operating on over 30 countries. Following a successful period of growth the company has is expanding with this in mind they are looking to add an Experience Regulatory Affairs Manager. With a new and fully integrated pharmaceutical manufacturing facility producing active chemicals and pharmaceuticals they are a growing business, in volume and diversity as they engage more customers expanding their portfolio.

Main Purpose of Role:

The role will involve balancing the needs and requirements of multiple over the counter involving development, manufacturing, packaging and distribution. This will require close interaction with all company functions as well as a high degree of external customer interaction. You will be responsible for project scheduling, resource planning and allocation, critical path analysis and conflict resolution so to deliver our projects on time and in budget.
This is a matrix management role, focused on the Project Management of oral solid dose (tablet & capsule) from R&D into commercial manufacturing and product launch to market. You will take a lead role in the both the project planning and project delivery. You will deliver new products to the market in the agreed timelines and enable accurate budgeting and resource planning to support the portfolio of projects. You will have budgetary responsibility for project costing's, which will need to be managed effectively during the life of the project.
Key Accountabilities:

*To manage the maintenance of regulatory licences as required
*To have responsibility for over the counter products
*To deputise as required for the European Regulatory & Drug Safety Director to ensure that the department is capable of responding quickly and effectively to the demands of the company

Skills & Knowledge:
*A degree (or equivalent) in life sciences
*Substantial experience in regulatory affairs, including hands-on experience with decentralised applications
*Experience in a supervisory capacity
*Experience with the information technology relating to regulatory affairs
*An appreciation of all aspects of the working of the pharmaceutical industry
*The ability to present the Company's interests in a professional and authoritative manner and to conduct negotiations with regulatory bodies at the highest level
*Exceptional eye for detail
*Membership of the Organisation for Professional in Regulatory Affairs (TOPRA) is essential


*To the successful applicant, my client is offering a salary of £40,000 - £47,000 + bonus + benefits based on skills and experience

How to Apply:

If this sounds like the sort of role for you and you have the relevant experience, please apply for this position below or contact on Matt Hart 01342 330 571, quoting reference number 932 119.

However, if this is not the role for you but you are looking for a new career position and you would like to know what other opportunities I have, please email or call me for a confidential conversation on +44 (0) 1342 330 571.

As a final point we will give you £200 if you refer someone and we place them……. so there's never been a better time to recommend a friend or colleague.

Job Title:Regulatory Affairs Manager - Pharmaceuticals
Pay:£40,000 - £47,000 + company bonus + benefits
Job Type:Permanent, Full Time, Office based
Company:Gold Group Ltd - client to be discussed upon application

This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Visit our website or get in touch today to discuss this role, find out what else we've got or just for a chat about the state of your industry. Services advertised by Gold Group are those of an Agency and/or an Employment Business.

Please be aware that we receive a high volume of applications for every role advertised and regularly receive applications from candidates who exceed the job credentials. We will only contact you within the next 14 days if you are selected for interview.

Company Name:

Gold Group Ltd


5th Floor East Grinstead House,Wood Street


Staffing Firms


United Kingdom


RH19 1U



less than 100




East Grinstead

Phone No. :

01342 330 500

For more information,visit

View all Gold Group Ltd Jobs

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