Head of EMEA Regulatory Affairs
- Experience Level
- Experienced (non-manager)
Head of EMEA Regulatory Affairs - Berkshire
Our client is an innovation led transnational pharmaceutical company producing a wide range of generic and branded formulations. The behaviour of their leadership team and people has created an environment where entrepreneurship and innovation thrive.
They are currently seeking a talented Head of EMEA Regulatory Affairs to work from their Slough offices.
Reporting to the VP Scientific Affairs EMEA, you will manage a group of regulatory professionals in supporting submission of various generic, inhalation device and specialty products to European and UK health authorities. You will coordinate the various developmental activities for timely submission of registration and maintenance documents. This will include coordinating various submissions particularly those associated with device requirements according to MDR. You will work with QA and PV groups to develop processes to ensure regulatory compliance with regards to submissions activities and develop regulatory intelligence and training for the regulatory group. This will require you to act as senior regulatory interface with global RA as well as with the UK affiliate organization where this position will be based.
- Experience in managing an RA group
- An excellent understanding of European regulatory requirements
- Significant EU regulatory experience, designing regulatory strategy, leading scientific advice procedures, managing regulatory approval processes and line extension applications through to the granting of the MA
- Managing the product lifecycle, including Marketing Authorization submissions, (DCPs, MRPs), post-approval line-extension and variation strategies
- Proven success in the effective management of timely approval of regulatory procedures
- Broad understanding of the requirements to place products on the market within EU
- Experience with Regulatory Affairs and Microsoft Office software and databases (e.g. eCTD publishing and validation, Amplexor, Eudralink, Excel etc.)
This is a great place to enhance your career with a dynamic, talented and diverse workforce holding its corporate values and people agenda at the heart of its operations.
A Highly Competitive Basic, Bonus and Benefits package will be offered.
Please apply online or call CHASE to find out more on 0131 553 6644.
Reference number: 31563