Senior Associate Regulatory Affairs : London UK
Our client, a Global Pharmaceutical Company is looking for a Senior Associate in Regulatory Affairs for an initial 12 months contract. The rate of pay for this role is £30-£35 p/hr depending on experience. Hours of work: 7.5 hrs - 37.5hrs.
- The Regulatory Professional will contribute in implementation of regional strategies by leading the execution of the preparation of CMC components of filings for one or more products according to the CMC timelines under the direction of the regional lead.
- Responsible for organization and preparation CMC documents for filings from marketing authorisation to post-approval supplements, renewals and responses to questions across all regions.Participate in the gathering, consolidating and analysing regulatory intelligence for all regions
- Responsible for documenting CMC submissions and archiving documents in document management systems.
- Authoring of redactions for use in emerging markets for all application types.
- Coordinate reviews and QC of regulatory documentation
- Strong communication skills - oral and written organisational skills
- Understanding of drug development process
- CMC- specific regulatory knowledge & experience
- Ability to develop solutions to technical and organizational issues in order to improve performance and productivity
- Strong computer skills, including word processing, database document repository and project management software