Senior Regulatory Affairs Officer

Our client, based in Dartford, were established in 2011. UK owned they are now expanding and are looking to recruit aSenior Regulatory Affairs Officer.
Qualifications and Experience (as applicable):
Educated to degree level in science or equivalent experience.
Minimum 5- 7 years of experience in the Regulatory Affairs regulatory experience with new product introduction within the pharmaceutical industry covering both UK National and European regulations
Strong communication and project management skills
Proficiency in the use of MS Office suite (Excel, PowerPoint)
Ability to take initiative and work with different departments as a team player within the organisation
Strong problem-solving and analytical skills. Facilitation and Leadership skills
Job Description:
Manage life cycle/ post-authorisation changes for UK relating to CMC, clinical, safety and product Information changes.
Writing, Compiling and Publishing Dossiers for UK National & EU Submissions.
Knowledge of requirements of Minor and Major complex Variations.
Compiling information and data for amendments to marketing authorisations. Submitting the variations to marketing authorisations and working with the MHRA and other regulatory bodies to resolve any RFIs arising during review of these variations.
Sound knowledge on requirements of MA Transfer in EU territories, ...