Regulatory Affairs Specialist
Ecolab
full-time
Posted on:
Location Type: Office
Location: Vimercate • 🇮🇹 Italy
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Support to Cross-Functional European Projects to drive innovation and efficacy
- Manage diverse maintenance activities of Medicinal Product Licenses on the Italian and export market, like: Preparation and submission of variations, Creation and revision of packaging & promotional materials, Update of internal and official databases, Support audits & inspections
- Support the Pharmacovigilance system
- Monitor regulatory/pharmaceutical regulations for the relevant therapeutic areas and share information internally
- Assist other functions, like customer service and tender business with regulatory expertise
Requirements
- Bachelor’s degree or equivalent, preferably in life sciences (pharmacy, biology, or similar)
- Experience being in a similar position in the pharmaceutical industry or at health authorities
- Good knowledge of applicable pharmaceutical regulations – preferably with European registration procedures
- Basic knowledge of related ethical code of practice required for GXP compliance
- Strong written and verbal communication and organizational skills
- Ability to work independently and collaborate effectively with cross-functional colleagues at all levels of the organization
- Ability to multi-task and prioritize work
- Fluency in English (speaking, reading, and writing)
- Proficiency in Microsoft applications (Excel, Word, PowerPoint)
Benefits
- Ecolab is committed to fair and equal treatment of associates and applicants
- Equal Opportunity to Employment
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory expertisepharmacovigilanceGXP compliancepharmaceutical regulationsvariation preparationpackaging revisionpromotional material creationdatabase managementaudit supportinspection support
Soft skills
written communicationverbal communicationorganizational skillsindependent workcollaborationmulti-taskingprioritization