Medical Device Officer

Linthwaite, Huddersfield

Thornton & Ross “a company you can rely on”

AGILITY – do you have the flexibility and decisiveness to drive change?
ENTREPRENEURSHIP – will you thrive in one of the fastest growing pharmaceutical businesses in Europe?
INTEGRITY – we are driven by trust, respect and honesty, are you?
ONE STADA – communication and teamwork, it’s our path into the future together

About the Role:

A great opportunity to join a small, dynamic regulatory team that will involve the maintenance of an extensive portfolio of licenced pharmaceuticals/medicines (inc. Rx, OTC, branded, generic and THR (herbal) products) in addition to support of New Product Development (NPD) projects across the business.

Your role will directly support the Regulatory Team in ensuring that T&R, including its various company entities, is fully compliant with its responsibilities for licenced pharmaceutical products. This will involve compiling, publishing and submitting product licence variations (MRP/DCP/National) in-line with national authority requirements and in accordance with internal procedures.

The position is key in supporting regulatory project activities (inc. NPD), generating CTD dossier sections and contributing to the regulatory strategy of the company when required. As appropriate, you will act as the lead regulatory person liaising with other departments and external bodies on business projects as well as a company representative at appropriate industry regulatory meetings with the UK regulatory authority (MHRA) or trade associations (e.g. BGMA, PAGB).

In addition to the above you will help ensure relevant departmental IT systems and procedure working practices are kept up to date and reflect legislative requirements and best practice.

 

About You:

Can you do it? Yes you can, if you’re keen to add value and see results, thrive under pressure and have the can-do spirit that’s spearheading our success, bring those qualities, with the following

  • BSc in life science discipline or equivalent (or suitable experience within the pharmaceutical industry).
  • 1-2 years’ experience in licenced pharmaceuticals regulatory affairs
  • Experience with eCTD dossier preparation and licensing databases (e.g. FirstDoc/Docubridge/Register).
  • Experience of working on life-cycle maintenance regulatory activities for licenced medicines inc. experience with variation procedures (National and/or MR/DC)
  • Experience with pharmaceutical NPD and/or project management within the pharmaceutical industry (preferred but not essential).

What’s in it for you?

With 3 manufacturing locations in the UK, the Huddersfield site is the hub for our Zoflora® and Covonia® brands along with manufacturing some key medicines for the healthcare sector. This will give you the chance to be at a key site making an impact. We employ over 600 staff onsite, all of whom have the opportunity to progress as we focus on promoting from within and you can be part of that too. We offer competitive salaries, great benefits and a fantastic smelling work environment!