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
Senior Regulatory Consultant: Kinesys is seeking to employ a permanent, full-time Senior Consultant with a minimum of 7 years’ experience in Regulatory Affairs and a first degree or PhD in Chemistry, Pharmacy or a Biology-based discipline. Exposure to development projects and regulatory strategy is required, as is expertise in a range of regulatory applications, and interaction with Regulatory Authorities. Experience with Pharma, Biotech and / or Consultancy companies will be valued, as would a previous role at a Regulatory Agency as an Assessor. The ideal candidate will enjoy working in a fast-moving environment on a variety of different project types and product areas. Hands-on experience with Orphan products, Biotechnology agents and in Oncology will all be a definite advantage. Similarly, experience with expedited or adaptive pathways, PRIME, EAMS / PIM and Breakthrough Therapy Applications, will also help to differentiate candidates for the post. The position can be based at our central Glasgow office or, for the right candidate, remote working may be possible.
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. This is a full-time, permanent role located at our central Glasgow office.
[Two roles] Regulatory, EU Associate Director level with strategy experience, one for large Biotech and one for large Pharma. 3-month minimum, on-site roles, both responsible for portfolio of Oncology development products.
Locations: Cambridge and Thames Valley
Regulatory: Associate Director level for UK affiliate role. 3 – 6 months on-site. Managing all UK affiliate / MHRA activities for group of marketed products.
Location: Thames Valley
How do our Contracting Services work:
Very simple. Our esteemed clients regularly ask for a specific profile for a defined role, with estimated contract duration. We constantly update and maintain a database of highly experienced consultants and contractors who are carefully selected and are, therefore, known to be suitable for the typical projects that our high quality clients are running. With Kinesys’ lengthy and broad experience in industry we are exceptionally well placed to find the right person for our clients, and the right job for our selected consultants and contractors.
How to apply:
Are you a new consultant or contractor looking for a position? If so, please follow the instructions below:
- Please send a full CV to firstname.lastname@example.org
- 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.
- Kinesys will then contact you to conduct a short interview and to discuss further your objectives and potential roles.
- We may post a summary of your profile on our website with your agreement.