Senior Regulatory Affairs Executive

Senior Regulatory Affairs Executive - Pharmaceuticals

The Senior Regulatory Affairs Executive would be an experienced regulatory professional with an understanding of and a recent background in either clinical study regulatory submissions or the compilation and submission of marketing authorisation or maintenance applications within Europe, although experience of US and other market submissions would also be an advantage.

A relevant scientific and academic background to at least the equivalent of BSc and a minimum of 3 years prior regulatory experience gained either within a CRO or small to medium sized European or European focused pharmaceutical company.

A thorough working knowledge of all aspects of European regulatory affairs is a critical requirement.

Familiarity with current electronic submission packages and European submission routes would be a distinct advantage.

Specific roles and duties:

- Within organisational constraints, participate in the development, delivery and utilisation of effective registration strategies.
- Provide regulatory support and guidance to internal and external development teams and partners as required.
- Undertake any assigned regulatory projects.
- Maintain current regulatory awareness and together with line manager provide strategic regulatory guidance and support to the organization.
- Contribute to the development and maintenance of departmental systems to ensure regulatory compliance.
- Participate alongside other colleagues in internal project teams, as required.

Candidates should hve the following experience and skills:

- MRP's, DCP's and CP's
- MAA's, Maintenance and Variations
- Full lifecycle management
- Clinical trial application experience
- Submissions in the EU, Middle East and some emerging market experience

This is a permanent position based in Reading offering a salary of circa 40k plus benefits.

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