Subject Matter Expert - Regulatory

Gold Group Ltd

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :

Master of Science

Address 1 :

United Kingdom,Hertfordshire,Hertfordshire,

Key Skills :

subject matter expert regualtory clinical non-clinical

Salary :

£60000 - £85000 per annum + bonus + benefits

Date Posted :

16 May, 2016

Company Name :

Gold Group Ltd

Location1 :


Job Category :

Biotech Jobs

Experience :


Job Type:


Travel Amount:



Job Title:Subject Matter Expert (SME) - Regulatory Affairs
Specialist Area: Pharmaceutical, Biologics, Non-Clinical (Clinical advantageous)
Pay:£60,000 - £85,000 + benefits
Job Type:Permanent, full time, office based with local and international travel
Company:Gold Group Ltd - Client to be discussed upon application

The Company

As an independent process / product development and regulatory affairs consultancy, the Group has established a particularly strong reputation in the field of biologics.

Following the founding as an independent, privately owned company in 1993, a subsidiary, was launched in London, which is now the company's largest single consulting operation, dedicated to biologics consulting, including advanced therapy medicinal products (gene and cell therapy products).

Thereafter, subsidiaries were incorporated in the US and Australia, in Washington, DC, and Brisbane, respectively. More recently, a further subsidiary was established in Hertfordshire, providing core regulatory affairs services and dealing also with small molecule drugs and generics.

This a newly created position within the company with the vacancy in all likelihood reporting in to the onsite Director

The Position

It is envisaged that the Subject matter expert (SME) will be situated in the Hertfordshire, but will have responsibility for operations across the whole organisation. Each office has at least one, in some cases two, employees at director level, but these directors are responsible each for their own teams and services, although cooperation across the offices is encouraged.

You will have an established experience in biologics drug development regulatory affairs, particularly the non-clinical area (clinical also beneficial)

It is a non-management position, but as the ideal candidate you will be expected to provide senior guidance to teams across the various offices

It will be expected for you to take on (project management and regulatory support) critical projects and client support tasks as required.

Essential Qualifications ,Skills & Knowledge to Succeed within this position:

*The successful candidate for this position will be a sophisticated manager with a scientific education in the life sciences (preferably with a Ph.D.) and will have experience in a related service industry.
*You will have actually done the work rolled up your sleeves throughout your career. Therefore, you not only understand your challenges, but the details within those challenges. You will have the specified requirements, written test scripts, supported data validation, documented business and conversion processes, and managed critical projects.
*As a SME you will have a documented history of working in the area for which you are an expert.
*You understand the Pharmaceutical and/or the Biologics Industry best practices and can communicate those insights to help you improve your business model.
*As a SME you will be able to lower project costs by effectively delivering project tasks more quickly and more accurately
*You understand user needs. When you design a product to meet a need, you're addressing the problems, concerns, or desires of the people who will utilise it on a regular basis.


To the successful applicant, my client is offering a salary in the region of £60,000 - £85,000 + benefits dependent upon 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, quoting reference number 932 036.

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.

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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