CK Group is recruiting for a permanent Regulatory Affairs Officer to join a global pharmaceutical company, based at their Bracknell site.The Regulatory Affairs Officer is responsible for providing regulatory support for an assigned number of marketing products and development compounds in UK, Ireland and Malta.Main Responsibilities:
As a Regulatory Affairs Officer you will require the following:
- Provide full regulatory support across the full life cycle, from pre-launch, launch, maintenance, discontinuation, and divestment.
- Preparation and submission of licence variations, implementation of SPC and pack copy updates.
- Use of global regulatory databases.
- Support audits and inspections and the investigation of non-compliances or other issues.
- Degree in a suitable scientific subject.
- Some experience in regulatory affairs in the pharmaceutical industry.
- Excellent written and verbal communication skills.
- Strong IT skills and aptitude for working with databases.
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54375 in all correspondence.