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