|Location: Manchester, Greater Manchester||Salary: £35000 - £40000 per annum|
|Sector: Life Sciences||Specialism:|
|Type: Contract||Contact: Jeremy Farley|
Job Title: Regulatory Affairs Officer
Salary: £35,000 - £40,000
Term: 12 Months Fixed Term Contract
Key Skills: Regulatory Affairs, Pharmaceutical, FTC, eCTD, SOP, CMC, Module 3, Gap Analysis, Medical, EU, Life Science, SmPC, Manufacturing
An experienced Regulatory Affairs Officer is required to join my client to join the Regulatory Affairs team in the preparation or variations and new marketing authorisation applications within the UK and Europe.
Working from site, this is a truly fantastic opportunity for the right person. If this sounds like an opportunity for you, please read on!
So, what will you be doing as a Regulatory Affairs Officer?
- Maintenance of marketing authorisations
- Reviewing, writing and advising on SmPC and artworks in line with current legislation
- Carrying out of compliance reviews of internal & external manufacturing and other site documents - Batch packaging & manufacturing records, stability protocols, Quality Control
- Writing & reviewing of SOPs & work instructions
- GAP Analysis/MA Review
- Provide assistance to the Pharmacovigilance Provider with Medical queries
- Management of various regulatory projects - Provision of advice, strategies
What are we looking for in our next Regulatory Affairs Officer?
- Degree Educated in Medical Sciences, Pharmaceutical Sciences
- Minimum of 3 years' experience in Regulatory Affairs
- Strong regulatory background with knowledge of EU Regulatory processes and legislative procedures
- Experience in compiling eCTD
My client is keen to get this position filled ASAP, so if you feel you have the skills and desire to provide passion and drive as the next Regulatory Affairs Officer, this is the opportunity for you!
So, if you are interested in joining a well-established, renowned, globally recognised organisation working with experts in their field as the next Regulatory Affairs Officer, hit that apply button now!