Full-Time Senior Regulatory Specialist

Key Responsibilities:

• Prepare and manage marketing authorization (MA) submissions, including local administrative documents, quality control (QC), and compilation.
• Provide ad hoc regulatory advice on submission packages in the post-authorization stage.
• Review and provide linguistic input for local Product Information and Mock-ups.
• Serve as primary contact for regulatory affairs (RA) matters with national competent authorities (NCAs) and/or clients.
• Involve in project management of the network of local contact persons for Regulatory affairs
• Collect, process, and manage regulatory intelligence for updates.
• Propose marketing authorization strategies tailored to client needs.
• Act as a deputy for the line manager when required.

Qualifications:

• University education in Natural Sciences, Chemistry, Medicine, Pharmacy, or Pharmacology
• Previous industry experience is essential
• Knowledge of Regulatory area and applicable legal and other requirements (local and global)
• Excellent organizational skills with the ability to manage multiple projects and deadlines
• Collaborative mindset, coupled with excellent communication skills
• Advanced knowledge of English (written and verbal)
• Experience with centralised procedures advantageous
• Experience with regulatory databases and dossier management software advantageous

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