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Global Regulatory Leads

Employer
Broughton Nicotine Services
Location
Remote Based, with travel requirements to Lancashire/North Yorkshire office when required
Salary
Competitive
Start date
9 Feb 2021
Closing date
11 Mar 2021

Job Details

Do you want to be part of a fast-growing, globally recognised scientific and regulatory company?

If you do, we want to hear from you as we have a number of exciting regulatory roles within our growing team.

Global Regulatory Leads wanted in Clinical, Non-clinical and Quality to cover Medical and consumer product regulations.

As BNS ramps up its Regulatory Affairs capabilities, we are seeking applicants with around 5-10 years industry experience in designing strategic approaches and delivering product submissions to global regulatory agencies with specialisations in any of the above disciplines.

Main Purpose of job

Broughton Nicotine Services are a contract research organisation providing analytical, scientific, and regulatory support to businesses in the e-cigarette and other sectors which cover both consumer products and medical products to be used for nicotine replacement therapy enabling them to increase the value of their business and advance a smoke-free future.

As BNS in-house subject matter expert on regulations relating to CMC/Quality, non-clinical, clinical or medical device requirements for nicotine and non-nicotine projects whether for a commercial or a medical indication, you will advise clients on the particular requirements for their products and work with the pharmaceutical development and other departments in BNS to ensure that these requirements are delivered either pre submission or in life cycle management.

  • Graduate degree in science
  • 5 years experience in CMC/Quality Regulatory Affairs
  • Experience of interaction with Regulatory agencies e.g. FDA, MHRA, EMA
  • Formal Regulatory Affairs professional qualifications preferred
  • Pharmaceutical or tobacco industry experience

Company

Broughton Nicotine Services is a privately-owned global Contract Research Organisation (CRO) offering fully integrated end-to-end services to deliver US Premarket Tobacco Product Applications (PMTA), EU Medicinal Product Applications (MAA) and EU Tobacco Product Directive (TPD) notifications. Our business culture is to continue to invest in new science and innovations. By partnering with Broughton Nicotine Services, our clients will know they have access to some of the most experienced ENDS project managers and scientific professionals in the world, combined with regulatory-compliant CRO laboratory facilities. We are committed to helping our clients develop safer nicotine delivery products.

We are bound by a common vision and team culture to delight our clients.  We have an undeterred competitive spirit that focuses on your success. Our commitment is absolute, we will not settle for less.  We combine a culture of quality with smart thinking and hard work to deliver better, faster and more efficient analytical solutions.  Working within regulated industries is an exciting and challenging market to build enduring partnerships; we believe that by working together, we can discover, develop, and deliver the best value for our customers.

Company info
Website
Location
Oak Tree House
West Craven Drive
Earby
Lancashire
BB18 6JZ
GB

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