TMC Pharma Services is a unique niche pharmaceutical development organisation based in the UK with worldwide capability. Our clients include all types of pharma companies, from large multinationals to small innovative biotechs/virtual organisations.
After another very successful year, we are again expanding our regulatory team and are therefore looking for a self-motivated regulatory affairs professional who enjoys working on a variety of projects and in a fast paced, innovative environment.
We are seeking a self-motivated clinical trial Regulatory professional already having experience as the global regulatory lead on clinical studies and able to provide that added value regulatory input needed in cross-functional study teams. The right candidate will be very familiar the EU CTA requirements and have hands on experience of working with US and ROW markets. Projects will be in a variety of therapeutic areas; including Advanced Therapy Medicinal Products and Orphan Drugs. Whilst being a global regulatory lead will the main responsibility, there will also be opportunities to support our Regulatory Directors on EU and global regulatory strategy and development work including scientific advice, PIPs, orphan drug designations and MAAs. Working with our network of expert associates, your involvement in the various elements of drug development is likely to include a much broader range of activities than in a typical regulatory role in pharma companies or CROs.
For the right candidate, TMC Pharma offers a very competitive salary (including potential for a profit-related annual bonus) and great benefits, including private health insurance and an employer pension scheme. Working within a fun, fast-paced, unique environment, we also have an on-site gym.
Nicola Kidman, VP of Regulatory Services,
Please note that calls from recruiters will not be taken and we do not require such services for this opportunity
Functional Area: Clinical Development
Based: TMC Office, Fleet, UK, global travel as required
Package: Excellent Salary and benefits package
Established in 2001, TMC Pharma Services Ltd (www.tmcpharma.com) is a successful, independent, European specialty pharmaceutical services company. TMC’s reach is global and its range of services is broader than even the largest service organisations. TMC’s head office is based in Hartley Wintney, near Fleet in Hampshire, where a core team of senior personnel manage a network of over 300 Associates located around the World that provide unparalleled expert services to Pharma and Biotech clients.
TMC’s focus is to provide support to, and partnership with, smaller companies throughout a development programme; and beyond if required. We have particular and significant expertise in the development of niche and innovative products.
Leadership of crossfunctional matrix programme teams (including Clinical, Medical/PV, Regulatory, Nonclinical and CMC functions) to ensure quality and timely overall operational execution of projects in accordance with our clients’ needs.
A confident, creative problem solver with excellent organisational, communication and presentation skills, who demonstrates leadership and ownership of project deliverables. He/she should:
To apply for this position please submit your full CV and covering letter to Damien Mair, Company Portfolio Director, TMC Pharma Services, email@example.com
We are always seeking highly experienced, freelance associates, across the globe in the following areas;