Career Opportunities

TMC Pharma Services is looking to add the following full-time roles to our friendly and professional team

Regulatory Manager/Senior Manager

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.

The Role

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.

Desired Qualifications, Skills and Experience

  • A life science degree (or equivalent)
  • Previous hands-on experience of global clinical trial applications and being the global regulatory functional lead for studies
  • Excellent collaboration skills to facilitate working with experts in all areas of drug development
  • A can-do attitude! Ability to work under own initiative, comfortable to run and lead projects and to be client-facing
  • Enjoy business development, preparation and management of project budgets, project planning and adding creative flair to daily work
  • Strong software and computer skills, including MS office applications
  • Eligibility to work full-time in the UK
  • Happy to be office-based full-time in Hartley Wintney, (near Fleet) Hampshire, UK
  • A good sense of humour and a love of dogs is essential!

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.

Please contact:
Nicola Kidman, VP of Regulatory Services,
nicola.kidman@tmcpharma.com

Please note that calls from recruiters will not be taken and we do not require such services for this opportunity

Director/Associate Director, Clinical Project Management

Functional Area: Clinical Development
Based: TMC Office, Fleet, UK, global travel as required
Package: Excellent Salary and benefits package

The Company

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.

Job Summary

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.

Responsibilities

  • Development of overall project plans and project budgets for approval by Clients. Communication of all aspects of the project plans (schedule, budget, resource, options, assumptions and risks) throughout a project, ensuring these plans comply with overall Client strategy
  • Continuous team leadership and oversight to drive projects to pre­empt and address issues ensuring completion with high quality, in the right timeframe, at the agreed cost
  • Work with external partners, Associates and Vendors
  • Design, develop and improve project management tools and processes, implement QA/QC activities as required

The Ideal Applicant

A confident, creative problem solver with excellent organisational, communication and presentation skills, who demonstrates leadership and ownership of project deliverables. He/she should:

  • have a first degree in Science/Pharmacy/Engineering/Technology preferably have managed clinical sites/studies and have completed some formal training in Project Management
  • have experience of global project or programme management, ideally with projects covering all development phases from pre­clinical to full development and registration

To apply for this position please submit your full CV and covering letter to Damien Mair, Company Portfolio Director, TMC Pharma Services, damien.mair@tmcpharma.com

We are always seeking highly experienced, freelance associates, across the globe in the following areas;

  • Regulatory affairs
  • Clinical Monitoring
  • Clinical Project Management
  • Subject Matter Experts; CMC, Non-clinical, Clinical