Company
Martindale Pharma is an established UK-based specialty pharmaceutical company; unusually it has its own UK manufacturing base and a track record of supplying individualised or difficult to make medicines for clinicians and pharmacists. Profitable and with annual sales of c. £100 million Martindale Pharma would rank in the top 5 independent pharmaceutical companies in the UK. The vision of the directors and shareholders is to create a fast growing international specialty pharma company which is marketing led, based on differentiated products and puts the customer at the centre of the organisation. Further details on broad strategy for the company and the five Business Segments in which it operates (specials, addiction, ophthalmics, critical care and hospital steriles) is highlighted on its website (www.martindalepharma.co.uk).
Summary of Role
Under the supervision of the Manager, the role holder is responsible for planning, organising and managing the activities for which they have been assigned within the Regulatory Affairs department ensuring that regulatory submissions are submitted correctly to the concerned authorities to agreed timelines. The role will ensure the individuals are motivated to contribute to the effectiveness of the overall team and departmental targets and objectives, and the wider business objectives.
Key Responsibilities:
Co-ordinate and / or prepare review, submit and subsequently manage applications to Regulatory Authorities in a timely manner. This will include:
- variations and renewal requests for existing authorisations
- prepare new marketing authorisation applications
- answers to questions and post registration / approval submissions
- clinical trial applications, ethical committee applications
- meeting packages for scientific advice and protocol assistance
- preparation of periodic safety update reports
- prepare and update previously approved summaries of product characteristics
- preparation and updating of previously approved product labelling texts and leaflets.
- Participate in cross-functional project teams covering
Compliance with QMS and compliance of products to granted MAs
Conversion of MAA dossier to CTD format
Procedures and quality policy
- Artwork / labelling
Collect, review, organise, assemble and check reports and summaries
Participate in departmental training programmes
Work with and provide support to third party contractors for assigned projects
Keep up to date with legislation and regulations and provide regulatory input to internal and external business partners
Liaise with regulatory authorities and experts relating to regulatory submissions
Provide information to the International and New Products Group as required.
Responsible for providing information and data on regulatory and other activities to their manager
Maintains good knowledge of relevant governance, SOP’s and ways of working
Qualifications, skills & experience needed:
Pharmacy, chemistry or life sciences graduate
Membership of The Organisation of Professionals in Regulatory Affairs (or eligible to be a member)
- Substantial Regulatory Affairs experience which includes the submission of variations, renewals new licence application submissions using as a minimum decentralised, mutual recognition and national procedures and preparation of PSURs.
- Experience in communicating and negotiating with the MHRA
- Experience in using Samarind Regulatory Management
- IT literate
- Understanding of e-ctd
- Able to work with and manage computer databases.
- Articulate, methodical, attention to detail, flexible, team worker, energetic, self-motivated, down to earth, entrepreneurial.
- An achiever and good listener
We endeavour to respond to all applicants. Due to large volumes, we are not always able to do so. Please note that if you do not hear from us within 2 weeks of the closing date, your application will not have been successful at this time and we thank you for your interest in the role.
EmoticonEmoticon