Regulatory Affairs Senior Officer

My client is an innovate full stage global specialist within immunology, specifically vaccines within allergies. They are seeking currently a candidate to work in their Barcelona offices focusing on both local and global submissions dependent on experience.
Ideally you will have extensive experience within pharmaceutical regulatory affairs including post-approval and CMC submissions and authoring of Module I-III documentation. On offer is the chance to work with a company which values high performing individuals and offers a clear career path for talented individuals.

Job 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
• Run regulatory projects or regulatory representative on company projects meeting timelines and costs of project
• Understand relevant legislative and regulatory guidance applicable to activities of the company. Particularly new areas like food, veterinary
• Prepare risk benefit analysis
• Active involvement in concepts of regulatory strategy
• Attend industry and RA meetings
• Review and sign off change control risk assessments
• Prepare & review assigned SOPs
• Train and mentor regulatory team members
• New product licence application dossiers in preparation for introduction of new legislation in Spain
• Review updates to the local regulatory environment and suggest impact at corporate level
• Prepare & review new product dossiers and annual updates and 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
• Regulatory Authority commitments, quality and safety reviews
• Preparation & review of general regulatory documentation such as Site Master File, Facilities licenses.
• Review updates to the regulatory environment and suggest impact at the company
• Provide local RA support to local Sales and Marketing departments
• Maintaining food supplements as per Spanish and European regulations.
• Prepare labelling/Packaging text. Review Promotional Material.
• Facilitate local contact/communication with local regulatory bodies (AEMPS & INFARMED)
• Prepare and update local SOPs
• Handling Translations
• Review Artwork and published SPCs (Spain)
• Deputy Local Safety Officer - Implement PV agreement between Central PV and LOC

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call David Nixon on +44 203 078 9544 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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