Regulatory Affairs Assistant

at  Well Pharmacy

Overview of the role
Preparation of regulatory submissions of pharmaceutical licenses to the local authorities and providing administrative support for filing & tracking of documents.

Main Responsibilities

• Ensure GMP principles are adhered to.
• Deal with all aspects of pharmaceutical PI licensing.
• Apply to external regulatory authorities for pharmaceutical licences and maintain licences.
• Communicate with the Procurement and Production department.
• Create and continually maintain Master Reference Files (MRF’s) for all granted licences.
• Create labels and Patient Information Leaflets.
• Source components from suppliers that are not produced in-house.
• Take part in initial and continuing training relevant to the job, based on written procedures.
• Maintain accuracy and quality of all documentation.

KNOWLEDGE SKILLS & EXPERIENCE:

• Must have a good communication skills.
• Knowledge of Microsoft applications.
• Good attention to details.
• Strong organisation and administration skills.
• Ability to digest complex regulatory procedures and legislation.
  The Ideal Candidate
  Well are proud to be a diverse and inclusive employer. If you have any specific requirements, we’ll do everything we can to support you. Whether it is to find a pharmacy that is accessible, or if it is a part time position you are looking for, we can help find the role that is right for you. If you need us to make any reasonable adjustments to our recruitment process, we will be happy to accommodate you.
  Please be aware that due to the high number of applications we receive it may not be possible for us to provide an outcome to all applicants. If you are not contacted within 28 days of your submission unfortunately you will have been unsuccessful.
  About The Company
  For over 70 years, we’ve been looking after the health and wellbeing of communities across the UK. Well Pharmacy (part of Bestway Healthcare) is the second largest pharmacy chain in the UK with c.760 pharmacies and a team of around 7,000 colleagues based across our Community Pharmacies, Online Pharmacy, Healthcare Services Centre, Community Drivers, Bestway Medhub & Wardles team and our Support Centre team.
  Our mission is to be here for the wellbeing of our patients and customers, to provide the best community pharmacy experience in the UK for everyone, for our patients, our customers, our people, and our NHS.
  The pharmacy of the future will look very different from the one we know today. It will play a huge role in transforming primary healthcare and we will play a central role in bringing it to life.
  We will use our clinical expertise and technological ambition to take advantage of the potential this future has to offer us. Making medicines, advice, services and care available in the places and spaces that people need and want it most.
  We want to be a great business. To be recognised as delivering a community pharmacy experience that is the best there is. To do this we want our teams to feel proud about the positive impact they make, feel valued as part of a close-knit and expert community, and feel confident in their role in a business that is stable, innovative, and caring.

• Ensure GMP principles are adhered to.
• Deal with all aspects of pharmaceutical PI licensing.
• Apply to external regulatory authorities for pharmaceutical licences and maintain licences.
• Communicate with the Procurement and Production department.
• Create and continually maintain Master Reference Files (MRF’s) for all granted licences.
• Create labels and Patient Information Leaflets.
• Source components from suppliers that are not produced in-house.
• Take part in initial and continuing training relevant to the job, based on written procedures.
• Maintain accuracy and quality of all documentation