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CK Group
,
London, Greater London
Regulatory Operations Manager
Overview
CK Group are recruiting for a Regulatory Operations Manager to join a company in the Pharmaceutical industry at their site based in Uxbridge on a contract basis for 12 months and has a hourly rate of £42.90 PAYE or £56.80 Ltd. The Company: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Our client has been a biotechnology pioneer since 1980. They have grown to be one of the world's leading independent biotechnology companies, reaching millions of patients around the world. Currently they are developing a pipeline of medicines with breakaway potential. The Location: This position is based in at their Uxbridge site, which opened in 2007. Uxbridge is located in the heart of the biopharma community west of London. It is ideally situated for easy access to all that central London has to offer. Uxbridge also boasts a significant and growing business population and is conveniently located just 15 minutes from Heathrow Airport. The Role: Responsibilities include: - Creation, submission and archiving of regulatory dossiers. - Maintenance of regulatory document management systems and tracking systems. - Maintenance of core dossier component structures. - Quality control of regulatory dossiers, archive and tracking systems. - Primary Regulatory Operations point of contact between TAs/CMC and publishing teams. Your Background: - Doctorate degree OR Master's degree & 3 years of directly related experience OR Bachelor's degree & 5 years of directly related experience OR Associate's degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience. - Previous experience leading projects, programs or directing the allocation of resources. - Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations and Regulatory Guidance. - Use of document management systems and databases. - Good written and verbal communication skills. - General understanding of industry practice and standards. For more information or to apply for this Regulatory Operations Manager position, please contact CK Group, quoting job ref 47970. It is essential that applicants hold entitlement to work in the UK.