MAIN RESPONSIBILITIES

As CMC specialist, the candidate will be responsible, with regular managerial guidance, for developing the technical eCTD sections to support Regulatory CMC dossier applications, both for clinical trial submissions as well as marketing applications and post approval variations.

The candidate, with the support of the manager and the CMC team, will provide technical oversight for the preparation of the Module 3, Module 2.3 and/or IMPD/IND, coordinating the timeline, virtual document, and the generation of the Quality module.

The candidate will author/drive, as appropriate, sections of the CMC dossier ensuring that the final versions comply with regulatory requirements and fulfill regulatory agency expectations.

The candidate will support the technical functions in the development of responses to health authority inquiries in support of clinical trials, as well as assists the team lead in preparing responses to marketing applications.  Evaluates and ensures the completeness, accuracy, and compliance of data provided for all regulatory submissions and that the quality submissions are completed in a timely manner.

QUALIFICATION

Strong chemistry technical/scientific background. Master Degree in chemistry or chemical related disciplines is a requirement, and a  PhD would be beneficial (or equivalent by experience)

Required Experience :

  • Minimum of 5 years’ experience in CMC for small molecules, even if additional experience would be beneficial (nice to have 5 to 10 years).
  • Solid knowhow of EU and US CMC regulations;
  • Strong CMC knowhow to support both new marketing authorization applications (Module 3 and 2.3 for NDA or MAA) Clinical Trial Applications (IMPD and IND), and post approval variations;
  • Capacity to follow scientific discussion and to lead meetings to agree with different type of functions the content of the regulatory dossier

Required languages:

English is sufficient

Required technical skills:

Confidence in using Microsoft suite softwares (Word, Excel, Power Point) and Teams (online meetings, sharing of the screen)

 

Fast internet connection (requested for Cloud PC usage)

Additional experience and/or skills:

  • Ability to work in complex organizations, where different functions have to collaborate to reach a team objective, and where it is requested to follow internal trainings, working procedures and guidelines.  A significant experience in a big multinational pharma company would be beneficial to demonstrate this skill;
  • Good communication skills and team working attitude, since it will be requested to represent the DDO team in multifunctional meetings, and/or in meetings with external companies;
  • Strong organization skills and ability to work independently (even if with senior guidance)
  • Ability to regularly take trace of the status of the activities, in order to share regular updates with the line managers
  • Good understanding of English language, both spoken and written
  • Good IT skills/knowledge
  • Pro-active attitude and able to work on own initiative as well as part of a team
  • Ability to prioritize different workloads/multi-task
  • Personal responsibility for ensuring a high standard of work

303 CMC Specialist

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