Description
Senior Regulatory Affairs ExecutiveLiverpool Area
£45,000 + Package
This role is made for a regulatory executive who is looking to progress and adapt in to a regulatory Manager. If you are looking for progression and the chance to take initiative, now may be the chance to do so.
MUST HAVES:
- Preservation of marketing authorisations (National, DCP and MRP)
- Preparing and submitting variations from type 1A's to type II's
- Preparation of variations and NEW MA applications in UK and the rest of Europe
- Submission of changes to the PIQU and other artwork changes
- Mentoring and training junior member of staff
- Reviewing, writing and advising on SmPCs and artworks
- Reviewing manufacturing documents: Including batch packaging records, batch manufacturing records, quality control requisitions.
- Conducting compliance reviews against internal documents, maintaining regulatory compliance of the company and carrying out gap analysis
- Construction of detailed compliance reports
- Managing implementation of timelines.
- Raising and reviewing change controls
- Acting as an border for the company and all third party clients
- Reviewing artworks in line with current legislations, amending as appropriate
- Working on projects - providing regulatory advice and devising regulatory strategies
Experience:
- BSc (hons) in Life Sciences, Pharmaceutical Sciences or equivalent
- Minimum of 4 years' experience in regulatory affairs, additional experience in industry beneficial (negotiable)
- Strong regulatory background with knowledge of regulatory processes and legislative procedures
- Experience in UK/IE and EU new applications and post submissions (MRP, DCP and National)
- Experience in NeeS/eCTD
- Experience in compiling and making changes to module 1 and 3
- Experience in internal and external site document reviews
- Excellent communication skills
Please feel free to share with Latifah a referral which may increase your chances in £200 worth of vouchers for one of the top high street retailers.
Latifah Khan