Description
Regulatory Senior Officer - Global Pharma/Generics - £35,000 - £45,000This global pharma/generics company is growing and expanding their team and is looking for a regulatory associate / office / executive
- Easy commute from - Cambridge, Essex, London.
This role requires:
- Minimum 18 months experience & up to 5 years in Regulatory Affairs
- Working knowledge of submissions, Variations
- To track all applicable regulatory changes and commitments to approval; ensuring implementation and all relevant personnel are informed or communicated.
- To assist the Head of Regulatory Affairs to implement the Regulatory Affairs strategy for the EU.
- Manage the submission process (generally DCP, MRP, CP or national submissions) including responses to requests for further information from Competent Authorities, managing the national phase for MA issue following closure of the European Regulatory
- To undertake regulatory affairs work as required. To generate high quality regulatory submissions to target markets throughout Europe in order to deliver a successful and timely portfolio of MA approvals in accordance with the company's requirements.
- Following MA approvals, maintenance of the MA approval activities including preparation and submission of variations and preparation for product launch. Successfully interact with the project and functional teams in India to ensure that data generated are appropriate and will be presented and compiled in accordance with EU requirements.
This is a role where you will be working in a small team of a large growing Global Generics company with the opportunity to work in and learn new various tasks and procedures. This department are known for their training and development of staff.
They say good people know good people so if you know anybody who might be looking at the moment please do put them in touch with me. Please forward to friends or colleagues in the industry. Should I place anybody you recommend you will receive £200 of vouchers for John Lewis. Please forward this email, sometimes people are not actively looking until they see a good opportunity.
This is a great opportunity not to be missed, please send me your C.V or call me to discuss the role further
Natalie Hopkins on or n.hopkins(a)realstaffing.com