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.
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.
- 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.
- 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:
PhD in Biology and Health
Consultant Professional Staffing Life Science and Deputy Manager