An excellent opportunity has arisen for a Regulatory Associate to begin their Regulatory career within an exciting emerging pharmaceutical company based in Berkshire. The role of the regulatory affairs associate will be to support the team in the preparation and submission of applications, and post approval submissions.
*Assist with the preparation and submission of applications of reliable quality in a timely manner to MHRA (UK) via National Procedure. These include new licence applications, variations (including grouping and work sharing), renewals, artwork changes, RFIs, updates and any other relevant applications or notifications.
*Work with QPPV on PSUR submissions, update SmPC and labelling in line with the Company Core Data sheets.
*Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.
*Maintain up-to-date records and documentation in relation to Marketing Authorisations.
*Carry out duties in line with regulatory, commercial, quality and business needs and ensure compliance with regulatory legislation and guidelines, and company processes and procedures.
*Support other regulatory staff members within the Company when necessary.
*Any other task given to you by relevant stakeholder in order for you to be able to perform your role
*Must have a 2:1 or above in either a Pharmacy, Chemistry or similarly analytical related degree
*1 years' experience in the pharmaceutical industry or related field although Graduates are welcome to apply
*A basic understanding of the current UK and European regulations, laws, guidelines and industry requirements is preferable but not necessary.
*High attention to detail to ensure the quality of documentation.
*Effective oral and written communication skills
*Excellent organisational and planning skills
*Ability to work independently
*Ability to interpret data
*Strong interpersonal skills; ability to develop and maintain cooperative working relationships with others and work in a team-based environment.
*Ability to use good judgment in order to carry out detailed instructions.
*Basic problem-solving capabilities
*Strong computer skills (including but not limited to Word, Excel, Powerpoint, Office 365).
*Ability to demonstrate calm objectivity in a pressurised, results driven environment, whilst successfully dealing with often changing and conflicting priorities
For further details about this role, or other roles within Regulatory Affairs, please contact Tim Barratt on 01727 817626 or email email@example.com