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...QA review of initial marketing authorization filings and variations, responses to health authority queries, briefing documents for scientific advice meetings; Performing compliance checks of the regis...
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...scientific or business disciplinesAt least 4 years' experience and/or equivalent competencies in legal/ pharmaceutical industry/clinical research.Excellent communication skills (both oral and written)...
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...scientific advice procedures.Familiarity with tech transfer processes.Proficiency in the use of project management tools and collaborative platforms.Fluent in English; French and/or Dutch are a plus.O...
- GSK
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- Hyper Recruitment Solutions
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.../ Health IT / data enablement / compliance / validation / URS / FS / IQ/OQ/PQ / risk assessments / CAPAs / GMP / GAMP5 / V-model / GxP / 21 CFR Part 11 / Data integrity / Collibra / Aetion / SASHyper ...