cmc officer.

The selected individual for the CMC Officer position will be expected to:

• Compiling pharmaceutical CTD dossiers in eCTD format, followup until MAs are granted, and life-cycle maintenance of the world-wide registration ofpharmaceutical products in regard to chemistry, manufacturing, control relateddocumentation.
•  Assist in the collection and evaluation of data to be included in module 3 of marketingauthorization dossiers.
• Respond to queries (from regulatory authorities or clients) concerning dossiers, manage theprocess to respond to the CMC questions by involving all stakeholders both within andoutside the company and following up agreed actions to respond as rapidly and completelyas possible.
• Assist in keeping the dossier core files (Module 3 and corresponding QoS) fully up to dateduring registration procedures and because of variations.
•  Participate in meetings related to registration procedures or when the CMC expertise isneeded. Tightly collaborate with the RA and R&D Departments for assigned products
•  Prepare the variation and post-approval change packages and other necessary documentsas required by the variation process.
• Ensure that all documents and records pertaining to the CMC Department are archivedproperly. Keep departmental database or other tracking system up to date.
•  Review regulatory compliance protocols and/or reports, as requested.
•  Participate in the change control system and variation process according to the establishedworkflow and contributing to renewal applications.

• minimum 2 years of experience in a R&D or CMC position

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Studies or related sciences. Arelevant postgraduate degree is considered an asset.
• Minimum 2 years of experience a R&D or CMC position.
• Directives as stated by European & National Regulatory Authorities.
• Knowledge of the scientific (chemistry, manufacturing, control) documentation andregistration requirements of the generic pharmaceutical products CTD dossier.
• Superb communication skills are required to liaise effectively with colleagues, clients,regulatory agencies, both verbally and in writing.
• Excellent knowledge and handling of both verbal and written English language. Knowledgeof any further language is an advantage.