Senior Regulatory Affairs Executive

Description

Senior Regulatory Affairs Executive - Leading Global Pharmaceutical Company - London based - Up to £40,000

Senior Regulatory Affairs Executive - Leading Global Pharmaceutical Company -Londonbased - Up to £40,000

We are currently working with a top Global Pharmaceutical Company who is one of the leaders in their field. Due to company expansion they are currently looking for a Senior Regulatory Affairs Executive to join their team inLondon. The role would suit someone who is looking for that next step up in their career with future aspirations for management. Paying up to £40,000 with excellent benefits the company are renowned for their excellent training and their career progression.

Key Skills/Experience

- Preparation and timely submission of key regulatory documents such as MA applications

- National/MRP/DCP, variations / post marketing changes.

- Communicate directly with notified bodies and other regulatory authorities to ensure product approvals are achieved in a timely manner.

- Maintain and organise appropriate regulatory records to demonstrate compliance with applicable regulations.

- Review and approval of Manufacturing, packaging documents, specifications and test procedures in accordance with registered dossier.

- Artwork/labelling approval

- Interfaces as needed with manufacturing, R&D and quality representatives to provide consultation on the impact of proposed changes to product, processes and the quality system. Ideally the candidate will have some experience of production operations, and be able to review and approve blank manufacturing documents and compare them to the registered dossier.

- Assisting in the developing and maintenance of in-house regulatory systems and procedures.

- Participate in regulatory inspections, if required.

- Supporting Quality functions such as audit, vendor qualification and oversight, CAPA, OOS, change control

The company are an excellent company to work for. They believe in a good work/life balance, show a lot of flexibility and they have a very friendly culture. They encourage career progression by offering career development plans and relevant training throughout your time at the company.

If this is of interest to you and you would like to find out more information on this position or any other regulatory affairs positions, please contact

To find out more about Real please visit www.realstaffing.com