Sr Regulatory Operations Specialist
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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.
Apply to discuss the Senior Regulatory Operations Specialist - Electronic Submissions role.
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