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SRG are currently looking for a Senior Registration Officer for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team on a permanent basis to be based at their office in Hatfield.The Role:
The Senior Registration Officer is responsible for providing regulatory expertise across UK and EU submissions and projects in a fast paced environment. Key Responsibilities:* Ensure suitable dossiers (marketing authorisation applications / post-approval submissions) are prepared and dispatched on-time according to agreed company procedures and objectives. Review data intended for submission and advise regarding any deficiencies or issues.* Ensure on-time submissions for all safety related changes for assigned projects.* Ensure databases and systems are updated in-line with current SOPs and up-to-date information is available for all assigned products.* Ensure SPPs for all assigned projects are maintained in-line with current SOPs and guidance.* Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities.* Liaise closely with Business Development (where required), Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives.* Prepare regulatory strategies (including advising of the regulatory requirements) for new marketing authorisation applications / post-approval submissions.* Be actively involved in due diligence activities including evaluation of regulatory strategy and launch timelines, evaluation of risks and regulatory costs.* Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects.* Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes.Skills/Experience Required:* BSc in Life sciences or related area.* Regulatory Affairs experience working in a pharmaceutical company is ideal.* Proficiency in speaking, comprehending, reading and writing English.* Excellent prioritization and time-management skills.* IT literate with proficiency in using word, excel, power point.