Hobson Prior are currently seeking a Technical CMC Manager Regulatory to join a Swiss global healthcare organisation who are focused on offering medical solutions in order to transform patients' lives. This position will be on a 6-month contract will the possibility for extension.

Job Responsibilities:

• Responsible for submission of high-quality CMC regulatory documents to health authorities.
• Actively contribute to the success of the technical regulatory team objectives.
• Support the development and communication of the regulatory strategy to ensure cross-functional alignment.
• Contributing to the timely regulatory approval of the organisation's products.
• Contributing to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.
• Ensuring cross-functional PTR deliverables (including assignments delegated by TRL) are completed compliantly, accurately, thoroughly and in a high quality and timely manner.
• Keeping TRL fully apprised of project status and potential submission risks and impact to defined regulatory strategies and timelines.
• Managing regulatory aspects of change control and ensuring appropriate communication to TRT team regarding management of technical changes.
• Provide regulatory support for relevant quality systems such as change control, discrepancy management, as well as Health Authority inspection support as required and/or serving as a liaison with the local health authority on behalf of the site.
• Supporting TRT team in making clear decisions.
• Help ensure cross-functional coordination and escalation, as needed.
• Supporting product related maintenance and Quality System activities as assigned (e.g., health authority commitments, health authority inspections, discrepancy assessments)
• Support departmental business processes to document and improve best practices and work efficiencies.

Requirements:

• Minimum 3-5years' work experience in pharma in Technical Regulatory Affairs.
• Hands on experience in the technical part of the dossier (dealing with regulations for Active Substance & tablets manufacturing).
• Health Authority management, extensive knowledge of regulations and guidelines of major regions (e.g. ICH, FDA, EMA, WHO).
• Educational background in Chemistry or Physics or Scientific background.
• Proficiency with a wide range of data/information (CMC, clinical, non-clinical safety, DMPK, quality, manufacturing, business operations in this area).
• Used to global matrix environment.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.