As a Senior Regulatory Operations Specialist - Electronic Submissions, you will manage electronic regulatory submission activities within the Life Science industry. You will help ensure submission documents are prepared, compiled and delivered in line with defined requirements and timelines.
Description
- 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.
Profile
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.
Job Offer
- 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.