Description
Role:Senior Regulatory Affairs Officer
Location:
West Sussex
Salary:
Up to £50,000
My client is looking for someone who can hit the ground running with this position. It is an amazing time to join this company, as they are a small company growing immensely. The reason they are looking to grow so quickly is simply because they have over 50 licenses that they need to carry out with. Products that you would be working with are solids.
Knowledge required:
- Experience of European & wider territories regulatory
- Experience with communicating with the MHRA at an administrative and strategic level
- guidelines, regulations and procedures
- Knowledge of other European Market Authorisation bodies eg IMB
- Knowledge of GMP and GDP
- Knowledge of MHRA fees
- Understanding of the timescales of the approval processes within the MHRA
- Understanding the company Reg Affairs SOP's
- Understanding of pharmacovigilance practices and procedures
- Understanding of the drug development process
Description:
- To ensure that the company's products comply with the regulations of the Medicines and Healthcare Regulatory Agency (MHRA)
- To ensure the company's manufacturer (MIA) and wholesale dealer (WDL) licenses are maintained and up to date to allow importation and distribution of all company's products
- To prepare submissions of license variations and renewals to strict deadlines
- To respond to questions from regulatory authorities raised during technical review of submissions, variations and renewals
- To write and review all SOP's within the regulatory department
- To keep up to date with the company's current and future product range
- To write clear, accessible product labels and patient information leaflets
- To manage the user testing of patient information leaflets when required
- To specify storage, labelling and packaging requirements in accordance with the product licences
- To undertake and manage all regulatory inspections
- To support regulatory affairs aspects for project management of new product development and launches.
- To manage payments and accounts with the MHRA for all UK company regulatory activity
Desirable skills:
- Ability to manage conflicting priorities
- Excellent communication skills
- Strong interpersonal skills
- Methodical and accurate
- Attention to detail and Proactive
If this is something you would consider then please do give me a call on .
Alternatively you could email me on L.khan(a)realstaffing.com
Referalls are always rewarded.
Kind regards,
Latifah Khan