Back Next Print Email to a friend Add to shortlist Apply

Senior Regulatory Global Operations Manager

25 Jul 2008

This is an excellent opportunity to work within a global operations role for a leading and ambitious biopharmaceutical company within an experienced regulatory operations group.

Salary: Competitive + excellent benefits package including a 15% bonus and car allowance.

Relocation: Relocation package offered

In the position of Senior Global Regulatory Operations Manager you will manage the operational activities for regulatory submissions across a range of therapeutic areas on a European and Global level. This position will manage a range of submissions such as INDs and major amendments and will be involved heavily in developing and maintaining procedures surrounding eCTD.

You will be able to contribute global expertise on regulatory submission teams regarding requirements on electronic document management, submission compilation, publishing, and the management of a variety of submissions.

Other responsibilities include:
Managing the workload of direct regulatory operations reports and monitoring their progress and training capabilities.
Developing best practices with Regulatory Affairs and other functions.
Serving as primary business point of contact for electronic document management and publishing systems.
Ensuring that the regulatory technical and format needs of the EU, US, and other markets are identified and incorporated into the regulatory plans for major worldwide submissions.
Liaising with global regulatory affairs staff regarding technical and format requirements on submission deliverables.
Interpreting local and global electronic submissions regulations.
Developing templates, processes and procedures to ensure compliance with regulations.

Skills and qualifications: Extensive experience in regulatory operations/publishing with experience in people management. Experience in the use of eCTD.

For further information please contact

David Nixon
Email: david.nixon@hayspharma.com

Services advertised by Hays Pharma are those of an Agency and/or an Employment Business