KEY RESPONSIBILITIES
* 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 Global 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.
* Flexibility and responsiveness in dynamic and changing environments.