Senior Regulatory CMC Associate

Job Details

Senior Regulatory CMC Consultant

Preparation of high quality, Chemistry manufacturing and control (CMC) detailed regulatory documents using varied information sources. Liaising closely with other Company personnel to ensure accuracy of such documents. Working together with other groups to ensure that ongoing projects are captured in these documents and that any changes are recorded. Ensuring that project work proceeds according to agreed deadlines and maintaining status records. Responsible for highlighting potential delaying factors promptly. Working with DCP/MRP and centralised registered products, Module 3 maintenance activities.

Required Experience:

*CMC experience
*Manufacture source transfer experience
*Experience of Net Change
*Change control advice, variations, Agency responses, renewals
*Be aware of the contents of a marketing authorization application.
*CMC Regulatory experience is required for these positions which are supporting manufacturing source transfers
*Experience of in-licensing preferred, but not essential
*Demonstrate team working and effective time management skills.
*Establish strong relationships and liaise effectively with internal & external Organisations worldwide.

Skills
*Be proficient in the use of IT packages such as Word and excel. Demonstrate problem solving skills.
*Good written and oral communication and networking skills.
*Demonstrate ability to focus and work with attention to detail.
*Demonstrate ability to retain critical information.
*Be a dynamic and highly motivated individual

Are you available or interested?

To Apply:

To apply, please click on the Apply button. Ideally, please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Luke Webber on +44 (0) 207 440 0635 or upload your CV on our website. Full description available on request.

Please note that not all of our vacancies are advertised. To register as a priority candidate, please upload your CV on our website with a short description of what you are looking for or call 0800 988 4437. We will then contact you with relevant roles: www.proclinical.co.uk. We regard all correspondence as confidential.

Proclinical is a specialist Employment Agency and Recruitment Business, providing employment opportunities within major companies in the Pharmaceutical and Biopharmaceutical industries across Europe.