An opportunity has arisen for a Regulatory Affairs Officer with an international pharmaceutical company located in London. This role reports directly into the Head of Regulatory Affairs UK. Key Responsibilities:
Skills & Experience Required:
- Coordinate and prepare MA, variation applications for submission via National or European procedures.
- Provide pharmaceutical, analytical and other technical information to affiliates, independent associated companies to assist with the registration and maintenance activities of existing MAs.
- With appropriate support, plan responses to questions from Regulatory agencies during MA applications, MA renewals and variations.
- Provide responses to regulatory questions relating to the group companies' products registered or undergoing registration.
- Assist with the maintenance of all MA's with appropriate support.
- Learn and be aware the current legislation, guidelines and other relevant technical and scientific information appropriate for the role.
- Maintain records of tasks and registered product information in the internal regulatory databases.
- Take personal responsibility for representing the Department both internally and externally in own area of expertise.
- Take responsibility for decision making within area of influence.
- Master's in pharmacy is preferred although any science graduate will be considered
- 2-5 years of experience within the pharmaceutical industry in disciplines such as quality assurance, pharmacovigilance, regulatory with at least 2 years in Regulatory Affairs.
- Key skills required are;
- Functional knowledge (UK Regulatory)
- Good communication
- Team player