Regulatory Affairs Apprentice

Brief Description

The role is working within the Regulatory Affairs team to ensure Parallel Import Licenses applications and variations are maintained in an effficient manner and in compliance with laws and regulations regarding importing of medicines

Qualifications Required

Candidate will ideally have achieved 5 GCSES's including Maths and English (C Grade / 4 or above) or equivalent;

Personal Qualities

? Self motivated
? Works well in a team
? Shares ideas and information
? Willing to ask questions
? Works to understand the regulatory process in great depth
? Has the drive to search for definitive answers for issues arising outside the scope of your current knowledge
? Commits to follow already-established procedures
? Assesses current procedures and offers up suggestions to make them more efficient
? Keeps pace with change to acquire knowledge and skills as the business develops
? Ability to work on their own initiative
? Can work well under pressure and with tight deadlines
? Ability to manage workload and to prioritise efficiently according to frequent changes in daily needs.

Skills Required

? Moderate to high level of computer literacy
? Moderate to high proficiency with Microsoft Word, Microsoft Excel, and Adobe Acrobat
? Excellent communication and literacy skills, including written and presentational skills
? Keen attention to detail and the ability to catch errors that others might miss
? High organisational capacity
? Ability to ?think on your feet?
? Ability to learn quickly and retain information

Future Prospects

This may lead to a long term permanent opportunity on successful completion of this apprenticeship

Vacancy Detail

? Help in the management & delivery of the processes & procedures of the Regulatory Affairs Department
? Prepare PI documents which are both accurate and of high quality, for submissions including new applications, licence variations, renewals and cancellations to multiple regulatory authorities Design labelling and leaflets to accompany pharmaceutical products
? Maintain relationships with regulatory authorities to expedite smooth and timely assessment of all PI applications
? Monitor for new pharmaceutical product information and keep existing PI authorisations up to date
? Implementing agreed document management policies and periodically auditing departmental records/databases to ensure information is kept up to date
? Keep abreast of changing regulatory procedures and relevant legislation
? Understand training in standards, procedures, policies, and records management tools
? Working closely with the Regulatory Manager and reporting back the Regulatory Manager regularly.

Other Information

Have you considered duration of this apprenticeship / pay rate and location is suitable?