Regulatory Affairs CMC Manager

Employer
Proclinical Staffing
Location
Cambridgeshire, England, Cambridge
Salary
Negotiable
Closing date
24 Sep 2020

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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A fantastic vacancy has become available for a Regulatory Affairs CMC Manager in Cambridge. This pharmaceutical regulatory affairs job is an excellent opportunity to work for a global leader in the life sciences industry.

Job Responsibilities

    Co-ordinate the preparation of high-quality CMC documents to support regulatory submissions in International regions, (Asia, Latin America, Middle East, Eastern Europe and Africa). Work with pharmaceutical development, manufacturing, QA and external partners to deliver the CMC components for marketing applications, variations and renewals Co-ordinate the preparation of responses to CMC questions from regulatory authorities Maintain an up to date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the organization in a timely manner

Skills and Requirements

    Must have significant experience in regulatory affairs and an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements Must be capable of the preparation and finalization of CMC regulatory dossiers and managing the ongoing maintenance of existing product licenses Well versed and competent with regulatory documentation and submission management systems Excellent verbal, written and interpersonal communication skills are required Must have excellent organizational skills and an ability to work on several projects with tight timelines

We hope to hear from you soon.

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Contact Us
  • Eldon House
  • Eldon Street
  • EC2M 7LS
  • United Kingdom
  • 0800 988 4437
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