Regulatory Consultant - Data Migration

An exciting opportunity has arisen for a Regulatory Consultant to join a global biopharmaceutical company based in Cambridge on a contract basis. A very patient-focused company, who scientific research has resulted in 15 marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.

Job Role:

• Provides support in the preparation of routine and straight forward regulatory submissions for approved products (e.g. Renewals and supplements to marketing authorizations) in line with regional requirements and scientific and company policies and procedures.
• May support routine labelling changes and drug listing as required, under guidance from immediate manager.
• Works to develop and acquire required regulatory skills and knowledge.
• May contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.
• Performs filing and data retrieval functions as directed, or in conjunction with departmental SOPs.
• Performs workflows and procedures regarding document tracking, indexing and retrieving and disseminating information to the Regulatory department.
• Seeks assistance from appropriate internal and external resources.
• Strong organization skills and attention to detail, along with the ability to work on a number of projects with tight timelines is required.
• Strong verbal and written communication skills and interpersonal skills are required.
• Must be proficient in Microsoft Word and Excel.
• Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas is required.
• Work is performed under the supervision of Regulatory Affairs professionals following detailed instruction with well-defined procedures.

To Apply:

Please click on the Apply button. 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 Peter Duvall on +44 203 0789 542 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.