AX-7257 Interim Regulatory Affairs Associate / Manager (UK & Ireland)
Interim opportunity to provide regulatory support to the UK and Ireland team of an established pharmaceutical company, focusing on marketed products and vendor oversight activities and supporting some EU activity.
Established Pharma Organisation – strong portfolio
Stand-alone UK & Ireland operational support role
Close collaboration with internal stakeholders
Office based in Cambridge with flexibility for some home working
This role would suit someone with previous experience in a CRO or consultancy who is keen on more industry exposure.
- Perform required licence maintenance activities for UK and Irish national MAs, including support for variations, renewals, licence withdrawals, artwork review and approval and responses to questions from regulatory authorities
- Liaise with outsourced teams and 3rd parties in the compilation and submission of regulatory applications
- Ensure business stakeholders are informed of all relevant regulatory updates in a timely manner
- Manage the maintenance of SmPC and PIL texts internally and on external websites
- Maintain awareness of the current priorities and regulatory needs of the UK and Ireland Regulatory Affairs department and plan and execute tasks according to the agreed schedule and priority
QUALIFICATIONS / EXPERIENCE REQUIRED:
- Educated to degree level (Bachelors or Masters) in a relevant discipline
- Previous experience in a Regulatory Affairs role, ideally at UK national level
- Candidates who are looking to transfer CRO and / or consultancy experience towards industry will also be considered
- Good understanding of relevant Regulatory Guidelines and legislation for the UK and Ireland
- Demonstrate accountability and a strong sense of ownership for your projects
- Possesses good written and oral communication skills
- Positive work style, with an approachable, flexible manner
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300 quoting reference 7257.
To apply, please click the APPLY ONLINE button.
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