Regulatory Affairs / Risk Management Student Placement

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About Mundipharma Research

Mundipharma Research is a dynamic organisation wholly dedicated to the research and development of highly effective and innovative medications. Based in Cambridge the company works on behalf of the independent associated companies and in collaboration with pharmaceutical companies to bring medications to both the European and International markets. We currently have in the region of 275 employees.

Mundipharma Research focuses on three main therapeutic areas – Pain, Oncology and Respiratory Diseases.

Regulatory Affairs / Risk Management Student Placement

Excellent opportunities for three Regulatory Affairs and one Vigilance Risk Management placements within Mundipharma Research in the following teams:

• Regulatory Strategy
• Regulatory Strategy – UK & Ireland
• Labelling
• Vigilance Risk Management

In these placements you will…

Carry out a variety of tasks depending on the role, typically including some of the following:-

Regulatory Affairs

• Preparing documents for submission (including forms, artwork and copy etc.) to regulatory bodies
• Ensuring documents and data are appropriately updated in databases and document repositories
• Monitoring and reviewing local regulatory guidance to ensure compliance of submissions
• Researching information to support the development of regulatory strategies for new products
• Assisting in maintaining company core data sheets (CCDSs)
• Assist in the preparation of product information documents

Risk Management

• Support the safety surveillance for all assigned products
• Prepare aggregate safety reports and risk management plans
• Provide safety expertise for questions/requests from competent authorities
• Ensure a competent level of labelling support (product characteristics and patient information leaflets)
• Support the team in the collation and analysis of reports, signal detection and evaluation, benefit-risk assessments and risk management plans as required

You’ll need to be…

• Studying toward a Life Science related degree
• Proficient in Word, Excel and PowerPoint
• Flexible in your approach to work and able to prioritise effectively
• An excellent communicator with the ability to develop strong relationships with people at all levels across the organisation
• Able to take ownership and work to tight deadlines, with good time management skills
• Passionate about working within a pharmaceutical organisation.

How to apply

We would like to understand more around your interest and motivation to join us by providing a cover letter with your application explaining in no more than 500 words into mundipharma@ckscience.co.uk:

• Why you are interested in working within our organisation, and what has attracted you to this placement in particular?
• What skills and qualities do you believe you can bring to this placement?
• What extra-curricular activities, including any societies or groups you belong to and/or volunteer work that you have completed.