Regulatory Affairs Manager (CMC) - Emerging Markets
CK Group is recruiting for a Regulatory Affairs Manager to join a company in the Pharmaceutical industry at their site based in Cambridge or Uxbridge on a contract basis for 12 months.
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.
Our client is flexible on the location of the role, allowing the successful candidate to be based at either of their UK sites; Cambridge or Uxbridge. There may also be some flexibility with up to two days per week remote work.
The purpose of this role is to lead regulatory projects for emerging markets commercialisation and life cycle management of assigned products. The role is multi-regional.
The Regulatory Affairs Manager will be responsible for:
- The development of regional strategy and execution of the preparation of CMC components of filings for one or more products.
- The organisation and preparation CMC investigational product amendments and post-market supplements, organisation and preparation CMC sections of annual reports (Canada Annual Notification, Brazil HMP)
- GMP registration of facilities
- Providing guidance on regional regulatory mechanisms to optimise product registration including expertise on regional regulatory requirements and precedence to cross functional teams.
To be considered for this role you should have prior experience in a CMC focused Regulatory Affairs position within Emerging Markets.
For more information or to apply for this position, please contact Jenni on 01438 768 710 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46463 in all correspondence.