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Cmc officer

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Randstad

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Location:
Greece , Athens

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Category:
Pharmacy

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Are you looking to grow professionally and make the most of your knowledge and skills in one of the leading pharmaceutical companies? If your answer is yes, this is your opportunity to pursue a career as a CMC Officer in the pharmaceutical industry.

Job Responsibility:

  • Compiling pharmaceutical CTD dossiers in eCTD format, followup until MAs are granted, and life-cycle maintenance of the world-wide registration of pharmaceutical products in regard to chemistry, manufacturing, control related documentation
  • Assist in the collection and evaluation of data to be included in module 3 of marketing authorization dossiers
  • Respond to queries (from regulatory authorities or clients) concerning dossiers, manage the process to respond to the CMC questions by involving all stakeholders both within and outside the company and following up agreed actions to respond as rapidly and completely as possible
  • Assist in keeping the dossier core files (Module 3 and corresponding QoS) fully up to date during registration procedures and because of variations
  • Participate in meetings related to registration procedures or when the CMC expertise is needed. Tightly collaborate with the RA and R&D Departments for assigned products
  • Prepare the variation and post-approval change packages and other necessary documents as required by the variation process
  • Ensure that all documents and records pertaining to the CMC Department are archived properly. 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 established workflow and contributing to renewal applications

Requirements:

  • Minimum 2 years of experience in a R&D or CMC position
  • Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Studies or related sciences
  • Knowledge of the scientific (chemistry, manufacturing, control) documentation and registration requirements of the generic pharmaceutical products CTD dossier
  • Superb communication skills
  • Excellent knowledge and handling of both verbal and written English language

Nice to have:

  • A relevant postgraduate degree is considered an asset
  • Knowledge of any further language is an advantage

Additional Information:

Job Posted:
December 09, 2025

Expiration:
December 30, 2025

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