Regulatory Affairs Quality & Compliance Senior Executive

A global pharmaceutical healthcare company are currently recruiting for a Regulatory Affairs Quality and Compliance Senior Executive for a 9 month interim period.

The main responsibilities of the role will include:

- Write high-quality CMCdocuments during development and product registration, contribute to CMC regulatory strategies, assure technical congruency and regulatory compliance by meeting agreed submission deadlines
- Identify the required documentation for CMC submissions and negotiate the delivery of approved technical source data and documents in accordance with project timelines
- Work with R&D and Quality colleagues to provide advice on EMEA CMC regulatory requirements
- Prepare CMC responses to health authority questions during development, registration and product lifecycle
- Create supporting documentation to ensure successful product lifecycle management
- Keep knowledge up to date with regard to quality guidelines and technical trends

The ideal candidate must have the following experience:
* Minimum 3-5 years of progressive experience in Regulatory Affairs with some Quality/CMCexperience essential.
* Demonstrated strong organisational skills, including the ability to prioritise workload.
* Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific and manufacturing.
* Strong sensitivity for multi-cultural/multi-National environments.

If this is a role of interest to you and you would like to discuss it further then please contact Peter Duvall at Progressive Pharmaceuticals on 02074695255

To find out more about Progressive Recruitment please visit www.progressiverecruitment.com