KEY RESPONSIBILITIES
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Authoring of CMC sections (Drug Product and/or Drug Substance) for new registration applications in CTD format, in alignment with general regulatory strategies and current regulatory guidelines.
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Authoring and reviewing CMC documentation to support variations and commitments resulting from interactions with Health Authorities.
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Partner with Global Regulatory Affairs (GRA) to support new registrations and worldwide post‑approval changes.
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Conduct Gap Analyses and/or Due Diligence assessments of the Quality sections of Global Dossiers.
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Ensure regulatory compliance of CMC sections for global products and drug substances throughout the product lifecycle.
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Evaluate the regulatory impact of quality-related change controls.
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Support QA in the qualification of Third Parties (CMOs).
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Prepare and/or publish eCTD sequences related to CMC content.
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JOB REQUIREMENTS
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Technical skills
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Degree in Relevant Scientific Discipline.
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At least 4 years’ experience in CMC. DP experience is preferable.
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Knowledge of relevant regulatory guidance’s.
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Knowledge of production (manufacturing, quality) and GMP compliance is value-added.
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Fluent in English (B2 required).
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Good knowledge of Microsoft Office package (Word, Excel, Power Point).
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Soft skills
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Strong attention to detail, with the ability to manage multiple priorities effectively.
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Demonstrated teamwork capabilities, including adaptability to diverse working and communication styles.
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High level of initiative and autonomy in driving tasks forward.
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Flexibility and responsiveness in dynamic and changing environments.