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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.
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.