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Regulatory Affairs Specialist

Company The CLINICAL TRIAL Company (USA) Inc
Location Durham, NC
Update 11 Day ago

Location: Durham, NC (home based)


Job type: Permanent

Company: The CLINICAL TRIAL Company (USA) Inc

An exciting opportunity has arisen for an experienced Regulatory Affairs Specialist to join The CLINICAL TRIAL Company (USA) Inc (TCTC), a world-leading full-service clinical research organisation (CRO).

TCTC has offices in the UK, Canada, Australia, Singapore and the USA. We operate throughout Europe, North America, South America, India, China, Africa and Australasia. Our expanding company provides clinical trial services and support to the pharmaceutical and medical device sector.

We are seeking a Regulatory Affairs Specialist with proven experience in US RA submissions, ideally clinical trials, BLAs, NDAs and European CTA and US IND applications as well as preparation of DSURs to join The CLINICAL TRIAL Company (USA) Inc. The successful candidate will require to consistently produce high quality regulatory and clinical trial documents, medical education and communications materials for the pharmaceutical industry and other educational bodies across a wide range of therapeutic areas.

This position will report to the Regulatory Affairs and Medical Writing Manager based in our UK Headquarters in Cheshire, UK.


The role will require you to hold a life science degree (Masters or PhD degree preferred) in a scientific field with a minimum of two years’ clinical trial regulatory affairs experience, within a CRO or pharmaceutical company. You will have a clear understanding of the requirements and responsibilities for safety reporting in International Pharmaceutical Trials and will have had exposure to Protocol Development and Writing and Clinical Study Report preparation. GMP, Marketing Authorisation and device experience would also be helpful for this role but is not paramount; a full driving licence together with a willingness to travel in Europe and North America is essential.

This is an exceptional opportunity within a career driven and progressive organisation offering excellent salaries and benefits.

Key skills required include fluent written and oral English language skills including familiarity with medical terminology and a professional/technical interest; good oral and written comprehension; professional communication; good numeracy and logical skills; first class attention to detail; professional communication skills; ability to work with minimum supervision and to prioritise tasks; computer literate; excellent time management skills; self-motivation and enthusiasm.

TCTC offers prospective candidates a truly exciting opportunity to join a growing and dynamic organisation, developing your career as the company grows. TCTC’s employees are vital to our success and so we are looking for candidates to join the company and to stay and grow with us. In return you will be rewarded with the opportunity to work on clinical trials of real scientific merit and with excellent opportunities for professional and personal development.

Key responsibilities

  • Responsible for the development and preparation of regulatory documents; trial submissions; medical information publications, including Clinical Trial Protocols; educational materials including Clinical Study Reports (CSR), CTD, and CRFs; scientific publications in line with regulation requirements; and internal document standards
  • Submission of regulatory applications, including trial applications and other regulatory submissions such as orphan drug, and paediatric investigation plans
  • Preparation of Patient material including Informed Consent forms and patient information leaflets for Clinical studies
  • Carefully take, correctly interpret and implement a project specification/brief, plus research, write, edit and proof copy to the highest standard (scientific and grammatical) for a full range of medical education and communications materials including scientific abstracts papers, posters, oral presentations, print items, and multimedia
  • Liaise with internal project teams, pharmaceutical industry key contacts, healthcare professionals and other external service providers
  • Check printer’s proofs (text, layout, colour, specification) and sign-off for print/production and provide direction for the development of creative designs
  • Assist the Regulatory Affairs and Medical Writing Manager with the provision of regulatory support for clients and internally
  • Assist in the development and documentation of TCTC processes

KEY WORDS: Regulatory Affairs; Medical Writing; Good Clinical Practice; GCP; GMP; Marketing Authorisation; Medical Device; RA submissions; BLAs; NDAs; European CTA; US IND applications: DSURs; Safety Reporting

Only applicants who have a legal entitlement and the requisite permissions to work in the US will be considered.

For further information on the role please contact Amanda Harrison, Group HR Manager on +44 (0)1565 733 772


Job Type: Full-time

Job Location:

  • Durham, NC

Required education:

  • Master's

Required experience:

  • Regulatory Affairs: 1 year
  • BLA submissions: 1 year
  • NDA submissions: 1 year
  • US RA submissions (clinical trials): 1 year