Description
Senior Regulatory Affairs Specialist (OTC EXPERIENCE PREFERRED)West London Area
£40,000 + Package (Negotiable)
This role is made for a regulatory specialist who is looking to progress and adapt in to a regulatory Manager OR move laterally within the company. If you are looking for progression and the chance to take initiative with a bubbly team this opportunity is something you may want to know more about.
MUST HAVES:
- OTC Experience or experience working with over the counter products (consumer health experience may help in this case)
- 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 & Ireland
- 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
- 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 2 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
Referrals also much appreciated with complimentary vouchers to Spend just after Christmas (may be useful for those who spent more than they imagined).
Latifah Khan