Regulatory Scientist
- Regulatory strategy: provide crucial support to RSIL and RRL in navigating complex regulatory landscapes and optimizing product strategies
- Stakeholder collaboration: drive alignment between regional and global strategies by actively engaging in collaborative working groups and fostering strong relationships with regional stakeholders and LOCs
- Documentation and processes: lead the development of streamlined regulatory submission processes and ensure meticulous review and management of regulatory documents, ensuring adherence to strict timelines and high-quality standards
- Clinical trials: offer expert guidance on CTA documents and deliver operational excellence in managing the assembly and submission of clinical trial applications, ensuring seamless execution of regulatory requirements
- Marketing authorization: play a pivotal role in supporting registration processes and maintaining dossier readiness, overseeing the preparation and submission of regulatory documentation with precision and efficiency
- General support: provide invaluable regulatory insight and support, ensuring compliance with regulatory standards, and representing Regulatory in cross-functional teams, while staying abreast of evolving regulatory landscapes
- Bachelors Degree in Pharmacy, Chemistry, Medicine, or Biotechnology
- 2+ years of experience in regulatory affairs within the pharmaceutical industry
- General understanding of the pharmaceutical industry and regulatory environment in drug development and/or marketed products
- High-level knowledge of regulatory submission requirements, including procedures, timelines, and documentation
- Ability to interpret guidance and apply it to submissions in relevant countries
- Understanding of compliance requirements with the ability to influence outcomes
- Proficiency in English (C1 level)
- Computer literacy, including experience with systems, databases, and relevant software
- Self-driven and collaborative, with experience working in multi-functional teams
- Attention to detail and exceptional organizational skills
- Opportunity to work for a global Big Pharma company
- Stable job environment
- International team
- Benefits package
- Hybrid or remote job
The offer applies to permanent work.
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