An excellent opportunity has arisen for a Senior Regulatory Officer to join a global team within a specialist Pharmaceutical company based on the South Coast. Within this role you will gain a large amount of exposure working closely with R&D, QA and PV teams. The ideal candidate will have a strong background in biologic or sterile products.

Job Specific Responsibilities:
*Ensure regulatory systems, such as Regulatory Database /trackers are implemented and kept up to date.
*Work with internal & external customers to provide data and accurate regulatory input
*Prepare & review labelling/Packaging text. Promotional reviews
*Communicate with regulatory agencies and document communication
*Prepare, Review and sign off change control risk assessments
*All paper and electronic files kept up to date and easily locatable
*Input into team activities e.g. brainstorming, best practices etc.
*Prepare & review assigned SOPs
*Prepare & review new product dossiers and annual updates
*Preparation & review of high quality timely submissions/responses and follow up of actions arising from Regulatory Authority commitments.
*Review and approval of CTA/IND submission and maintenance documentation
*Prepare & review new product dossiers and annual updates

Qualifications/Experience required:
*Relevant life sciences degree
*A background in biologic or sterile products
*Minimum of 3-5 years in the pharmaceutical field
*Demonstrated ability to write good quality documents
*Communication skills
*Attention to detail/accuracy
*Project management
*Breadth of technical regulatory knowledge & regulatory procedures in a variety of markets
*Proficient user of Microsoft Office


For further details about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on or email a copy of your CV to

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