Senior Regulatory Specialist
Job Summary
Acting as the Local Contact Person for Pharmacovigilance, the full-time Senior Regulatory Specialist will develop regulatory strategies, manage deliverables, and liaise with various stakeholders to ensure compliance with project and industry standards while working remotely.
Key responsibilities
- Lead coordination and management of regulatory deliverables for medium/high complexity projects
- Develop strategies and manage setup activities, including project management plans and core documents
- Provide training and mentorship to junior staff and foster relationships with internal and external contacts
Required qualifications
- Bachelor's Degree in Chemistry, Life Sciences, Nursing, or equivalent experience
- Strong experience within the pharmaceutical or CRO industry or regulatory body
- Good knowledge of ICH GCP and/or GVP and national regulations
- PV training and/or relevant working experience
- Fluency in English and proficiency in the official language of the designated country
Complete Job Description
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