Regulatory Affairs Officer

NOTE: this job is not remote, and based at our Doncaster Pharma HQ in Doncaster, UK

We are looking for a result orientated and organised Regulatory Affairs Officer who wants to join a dynamic and growing pharmaceutical company. Doncaster Pharma is a subsidiary of the Dutch BModesto Group which is part of the Irish and listed Uniphar Group.

Within the Regulatory Department, the Regulatory Officer will be responsible for submitting, maintaining, and implementing product files for Doncaster Pharma Limited and/or for third parties in accordance with MHRA guidelines or an equivalent Regulatory body.

We are Doncaster Pharma

We are a specialist pharmaceutical wholesaler located in Doncaster, UK. Founded over 35 years ago, Doncaster Pharma is one of the UK’s leading specialist pharmaceutical wholesalers. Doncaster Pharma has established a comprehensive network of partner suppliers throughout Europe.

Doncaster Pharma Limited are a parallel importer, where medicines are imported from Europe and are repackaged for the UK market. The industry is highly regulated, and the parallel importation is only legally permitted once the product has a product file which has been assessed by the relevant regulatory body. The product file contains all the information with regards to the packaging of the medicinal product and its patient information leaflet. The Regulatory Department are responsible for applying for new product registrations, along with the maintenance of said registrations.

Part of the BModesto Group

A collection of contrarious adventurers, with a sharp eye for details, who work together towards a higher goal: to make a positive contribution to the care and well-being of our loved ones. We therefore work hard every day to ensure optimal availability, accessibility and affordability of healthcare resources in the Netherlands and beyond. How do we do this? By supporting clinical trials with BMclinical, supplying (parallel-imported) medicines to hospitals and pharmacies in the Netherlands with BModesto, the UK with Doncaster Pharma, the same for the German market with SynCo pharma and supplying (parallel-imported) medical devices with BMmedical. As an employee of the BModesto Group you contribute to this!

Responsibilities

• Completely independently prepare product files (as per new and existing product registrations) and prepare them within the appropriate computer system;
• Carefully compare the reference product with the parallel product and ascertain a full comparison;
• Respond quickly and adequately to Requests for Further Information, received from Regulatory bodies, to be able to continue the registration file promptly;
• Establish when a variation is required, compile submission documents, and submit to the relevant Regulatory body, on time and in full and proactively monitor its progress;
• Where necessary, check the internal production documentation and other activities of colleagues;
• Prepare samples according to the guidelines of the relevant Regulatory body in a timely manner;
• Prepare and send both Specific Mechanism and Trademark notification letters to the relevant holders in a timely manner;
• Pass on changes to other colleagues in a timely manner and enter submissions within various spreadsheets;
• Report daily progress to the Regulatory Supervisor;
• Communicate timely and adequately with the Regulatory Manager regarding developments, opportunities and any risks during the registration process or general matters within the Regulatory Department;
• Be a team player and know how to achieve an optimal result together with the colleagues within the Regulatory Department;
• To follow a clear, defined training plan, with regular support from Regulatory management;
• The Regulatory Officer reports directly to the Regulatory Manager, with daily direction and support received from the Regulatory Supervisor.

What should you have?

• Minimum Secondary education or Higher professional education;
• At least 2 years of experience within an administrative position, preferably in a GMP environment;
• Can master the English language, both verbally and in writing;
• Good knowledge and experience within MS Office, experience with Adobe is an advantage;
• Knowledge within the pharmaceutical industry or related industry is an advantage;
• Having a precise and detail orientated mind is paramount.

This is you!

• Result orientated;
• Attention to detail;
• Flexibility;
• Loyalty;
• Team player;
• Planning and organisation.

What will Doncaster Pharma offer you?

• An exclusive onboarding box with unique items;
• Awesome company parties and events (check them out on our LinkedIn or Facebook page);
• A competitive salary with extensive secondary employment conditions;
• Company laptop;
• Excellent pension scheme;
• Possibility to follow training and courses in the context of personal development and / or job-related;
• Many career opportunities within the BModesto Group and the various entities;
• Enjoy every day in an enthusiastic team with adventurous and razor-sharp colleagues.

Job location: Doncaster Pharma HQ, UK

If you are interested in becoming Regulatory Affairs Officer, we would love to hear from you. Please send your resume and motivational letter to pz@bmodesto.com. If you have any questions, please let our HR-department know by mailing pz@bmodesto.com or call +31 320 216 387.