61 days ago on jobs.kellyservices.ch

CMC REGULATORY AFFAIRS _ Biotech Field

Kelly Services (Schweiz) AG

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 Please refer to JobSuchmaschine in your application

CMC REGULATORY AFFAIRS _ Biotech Field

Kelly Scientific is looking for a CMC REGULATORY AFFAIRS for our Biotechnology partner localised in the Western part of Switzerland. 

OVERVIEW:

This position serves as a point of client contact for Regulatory Affairs/Quality Assurance aspects of a project from beginning to end with accountability for assigned project deliverables.

RESPONSIBILITIES:

  • Support planning and tracking for CMC submission activities and work closely with the global RA team.
  • Handle troubleshooting and daily management of CMC regulatory submissions within process development.
  • Provide guidance for CMC on CTA, IND, IMPD, NDA and BLA and manage the compilation of the documents.
  • Knowledgeable in US and EU requirements for submission formats (eCTD for IND, IMPD, NDA, BLA).
  • Enable high quality CMC documents through content review and compliance submission ready standards.
  • Track new and updated global regulatory requirements and provides summaries to process development.
  • Maintain awareness of current trends in regulatory requirements through literature searches and networking.
  • Develop and maintain strong communication and collaboration with stakeholders.
  •  Actively manage QP declaration, QP certification, review of IB/PM, labelling and on time shipment of investigational product to distribution center.
  •  Perform other relevant duties as required.

REQUIREMENTS:

  • Pharmacist, PhD or equivalent with studies in biochemical engineering, biochemistry, biology or related discipline
  • Minimum 3 years of relevant Regulatory Affairs experience in a biotechnology industrial setting
  • Excellent communication skills and strong diplomacy skills required
  • Fluency in English, both written and verbal; French is a plus
  • Proven ability to work with flexibility in a changing and demanding environment
  • Ability to work independently as well as part of a team
  • Strong sense of discipline, exceptional organization skills, excellent team orientation and hands-on approach to work
  • Ability to work independently with proven experience in problem analysis/solving, anticipation and proactivity

Your contact at Kelly Scientific:
Mathilde DROMARD
PhD in Biology and Health
Consultant Professional Staffing Life Science and Deputy Manager