J56255HertfordshirePharmaceutical Biotechnology PermanentCompetitiveFull Time13/06/2018Regulatory Affairs Regulatory Affairs – UK Regulatory Affairs – EU Regulatory Affairs – Global Regulatory Affairs - Biologics
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An exciting opportunity for an experience Regulatory Affairs Officer has become available to join a leading Biologics company based in Hertfordshire but within commutable from London. As the Senior Regulatory Affairs Officer you will be responsible for Drug Product Information and Labelling documentation for Global markets.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Regulatory Affairs Officer will be varied however the key duties and responsibilities are as follows:
1. Provide input to master drug product labelling documents with regards to standard requirements for drug labelling and will have ownership over the Packaging Information Leaflet (PIL).
2. Give insights into drug labelling requirements for global markets and act as the Subject Matter Expert within the Regulatory team.
3. Contribute to the improvement of processes and procedures within the Regulatory Affairs Department and coach other members of the Regulatory team.
4. Actively advising on the optimal design/layout of presentations of marketed products and products in development.
To be successful in your application to this exciting opportunity as the Senior Regulatory Affairs Officer we are looking to identify the following on your profile and past history:
1. Relevant degree in a Scientific discipline is desirable but experience within a Regulatory Affairs environment is essential, ideally with extensive experience wing Drug Product Labelling.
2. Proven industry experience with global regulatory agencies will be a benefit to your application.
3. A working knowledge and practical experience with labelling and marketing regulations is a requirement for this position.
Key Words: Regulatory Affairs , Global Regulatory Agencies , Biologics , Labelling , Marketing , Product Information , PIL , ICON , HA,
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.