Job Reference: 1309-110
Job Duration: a.s.a.p
Start date: a.s.a.p
Description:
An excellent opportunity has arisen to join a leading Generics company at a Senior Regulatory Affairs Officer level. Within this role you will be responsible for managing EU registration and post approval activities as well as mentor junior staff and gain basic line management responsibilities.
The ideal candidate will be highly motivated and energetic and have a strong background in EU registration and post approval activities. You will have a strong understanding of regulatory affairs, ideally between 3 - 5 years, and have an excellent knowledge of MRP/DCP, National and CP submissions across the European markets. This is an excellent opportunity for a driven individual with excellent communication skills to join a world leading generics company. If you are looking to gain project and line management experience, this role could be for you.
Responsibilities:
- Ensure suitable dossiers (marketing authorisation applications / post-approval submissions) are prepared and dispatched on-time according to agreed company procedures and objectives.
- Ensure on-time submissions for all safety related changes for assigned projects.
- Ensure SPPs for all assigned projects are maintainedin-line with current SOPs and guidance.
- Liaise closely with Business Development (where required), Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives.
Provide mentoring and training to (Associate) Regulatory Officers and/or (Senior) Regulatory Assistants as directed by Line Manager.
Forfurther details about this role, or for a confidential chat about other opportunities within Regulatory Affairs, please contactTim Barratt on 01727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk
Industry: Pharmaceuticals
Salary: £40000 - £45000 per annum + bonus + excellent benefits
Salary Benefits: bonus + excellent benefits
Vacancy Type: Permanent
Job Skills: regulatory affairs,principle officer, principle regulatory officer, post marketing, CMC, generics, MRP/DCP, European, Senior Regulatory Affairs Officer, Senior Regulatory Affairs Associate
Contact Name: Tim Barratt
Website: -
Direct Application URL: -