• Collaborative and multicultural working environment.
• Competitive compensation and benefits package.

Sobre o nosso cliente

Our client is a leading international pharmaceutical organization with a strong global presence and a diverse portfolio of products serving patients worldwide.

Descrição

• Publish and manage regulatory submissions in eCTD and non-eCTD formats for global markets;
• Perform technical quality control and validation of electronic submissions to ensure compliance with Health Authority requirements;
• Coordinate submission schedules and ensure timely delivery against critical regulatory milestones;
• Act as the subject matter expert for publishing activities, providing guidance to Regulatory Affairs and cross-functional stakeholders;
• Troubleshoot publishing and validation issues, ensuring successful submission delivery;
• Support electronic transmission and archival of regulatory dossiers;
• Contribute to process optimisation, system enhancements, and publishing best practices;
• Maintain current knowledge of evolving global eCTD requirements, standards, and technologies;
• Support regulatory projects and system implementation initiatives;
• Mentor junior colleagues and contribute to knowledge sharing within the Regulatory Operations function.

Perfil ideal

A successful 'Senior Regulatory Operations Specialist - Electronic Submissions' should have:

• Degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related discipline;
• Minimum of 5 years of experience in Regulatory Operations, Electronic Submissions, or Regulatory Publishing within the pharmaceutical industry;
• Strong practical experience with eCTD publishing and submission processes;
• Experience with publishing software, ideally Lorenz docuBridge;
• Familiarity with document management platforms such as Veeva Vault and/or Documentum D2;
• Strong understanding of global regulatory submission requirements and electronic dossier formats;
• Proven ability to manage multiple projects and deadlines simultaneously;
• Excellent problem-solving and troubleshooting capabilities;
• Strong attention to detail and organizational skills;
• Effective communication and stakeholder management skills;
• Experience working within global, cross-functional environments;
• Fluency in English.

Vantagens

• Opportunity to join a highly regarded global pharmaceutical organization.
• Collaborative and multicultural working environment.