Regulatory Affairs Associate Manager

Job Details

An exciting and challenging contract opportunity has arisen for an experienced Regulatory Affairs Professional to join the Emerging Markets Regulatory Affairs team in Cambridge.

Job responsibilities:
*Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs for commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures
*Responsible for submissions which may include safety reports, amendments, supplements and license renewals and marketing authorizations), original, marketing authorization applications for territories other than the US and EU and for contributing to preparation of US and EU marketing authorizations). Provides regulatory expertise to labeling changes and to submission teams on specified projects and topics
*Provides input to senior Regulatory Affairs professionals in the preparation of country specific labeling. May be responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licenses
*Participates in group meetings and local and global product submission team meetings and present project status updates and strategy approaches to moderately complex programs/projects
*Responsible under guidance of immediate manager for own self-development and acquisition of required regulatory skills and knowledge
What we are looking for:
*Typically requires a BA degree in relevant discipline and relevant experience in Regulatory Affairs or related field
*Excellent organization skills and ability to work on a number of projects with tight timelines is required.
*Excellent verbal and written communication skills and interpersonal skills are required
*Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories
*Is recognized as a knowledgeable resource within the department on a range of topics
*Work is performed under minimal direction of a Senior Regulatory Affairs professional

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.