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Introduction to Employment Positions and Contracting with Kinesys Consulting Ltd

Kinesys Consulting provides Strategic Development, Regulatory Affairs and Technical Writing support and services to a highly varied portfolio of clients within UK, Europe and USA, as well as in emerging and other markets. Since 2007, we have been known as a high-quality service provider whose senior consultants have a wealth of experience and expertise across most biopharmaceutical product classes, therapeutic areas and regulatory applications. We regularly represent clients at EMA, EU NCAs, and US FDA for different types of projects and Applications, including at key regulatory meetings such as Oral Explanations and Appeals. The company benefits from a top class Advisory Board whose members are available to help resolve our clients’ regulatory, clinical, nonclinical and CMC challenges. Kinesys’ Head Office is based in Glasgow, UK, while some senior consultants are located in other parts of EU and USA. Kinesys provides consultancy and contracting services to many major pharmaceutical companies and to both large and developing Biotechnology firms. We also provide Non-Executive Director and Scientific Advisory Board members. We specialise mainly on filling our client’s more senior roles, for which significant relevant knowledge and experience is required. We do, however, receive requests for more junior positions, especially in regulatory affairs and writing roles.

Available employment and contract roles

Regulatory Affairs Executive (Job Description):

Responsibilities

Participate in client regulatory activities including working on projects such as:

  • Analysis of regulatory, CMC, nonclinical and clinical data related to a range of Regulatory Authority Applications (see below).
  • Project management of regulatory applications and procedures.
  • Writing and management of regulatory submissions, primarily to EMA, FDA, and National Competent Authorities in EU and, occasionally, outside of EU, including:
    • Scientific Advice applications
    • Orphan Drug Applications
    • Clinical Trial Applications
    • Paediatric Investigation Plans (PIPs)
    • Expedited Pathway Applications
    • Marketing Authorisation Applications
  • Search and review of legislation and guidance relevant to manufacture and development of pharmaceutical and biotechnology products.

Profile of person for the role

Kinesys is seeking a highly professional individual for this interesting and exciting role:

  • University degree in pharmacy, chemistry, medicine or a biological sciences.
  • Minimum 4-5 years in an industry or regulatory agency role.
  • Ability to work independently, show initiative and ability to multi-task, plan and work in a team.
  • Highly computer literate, possess good analytical skills and attention to detail.
  • Excellent command of spoken and written English. Other languages valued.
  • Ability to communicate effectively.
  • Good organisational and project management skills and ability to prioritise and work diligently to tight deadlines.
  • You are looking for a company where you will broaden your experience and grow with the company.
  • You will be process driven with a can-do approach to find fitting and effective solutions to move projects forward.

This is a permanent role, preferably located at our central Glasgow office, but remote working could be an option for the right candidate.

Please apply to info@kinesysconsulting.com with a CV and cover letter.

Medical / Regulatory Writer: 

Minimum 3 years working in a similar role at a Pharma, Biotech or CRO company and a first degree or PhD in Chemistry, Pharmacy or a Biology-based discipline. Preferably the candidate will have worked on Regulatory Applications such as CTAs, Orphan Drug Applications, Scientific Advice, PIPs, MAA Summaries and Overviews, as well as on clinical documentation (e.g. Protocols, CSRs, IBs, etc). The role is likely to involve working simultaneously on different technical, clinical and regulatory documents and Applications, and as such will suit a motivated professional able to multi-task and who enjoys a fast-moving environment.

Candidates should also fulfil the following criteria:

  • Ability to work independently, show initiative and ability to multi-task, plan and work in a team.
  • Highly computer literate, possess good analytical skills and attention to detail.
  • Excellent command of spoken and written English. Other languages valued.
  • Ability to communicate effectively.
  • Good organisational and project management skills and ability to prioritise and work diligently to tight deadlines.
  • You will be process driven with a can-do approach to find fitting and effective solutions to move projects forward.

This is a permanent, part-time or full-time role role, preferably located at our central Glasgow office, but remote working could be an option for the right candidate.

Please apply to info@kinesysconsulting.com with a CV and cover letter.

Spontaneous Application

Are you looking for a consultant or contractor position? If so, please follow the instructions below:

  1. Please send a full CV to info@kinesysconsulting.com.
  2. Please include a cover letter setting out a short description of your profile and experience, the type of position that you are seeking (role, contract duration, geographical preference, expected salary / fee) and any other relevant information.
  3. Kinesys will then contact you to conduct a short interview and to discuss further your objectives and potential roles.