Similar posts
CMC Manager
This vacancy has now expired. Please see similar roles below...
Proclinical is seeking a Regulatory Affairs CMC expert for an innovative client, to be based in Switzerland on a contract basis. As Regulatory Affairs CMC expert you will take a lead in documenting CMC submissions and archiving documents in document management systems.
Role Overview:
- Responsible for organization and preparation CMC documents for filings from marketing authorisation to post-approval supplements, renewals and responses to questions across all regions.
- Co-ordinate the preparation of responses to CMC questions from regulatory authorities.
- Apply agreed strategy for minor/routine submissions and query any apparent deviations.
- Track progress against regulatory strategy time-lines for submissions and alert leadership to potential discrepancies.
- Participate in interdisciplinary change management and evaluate the regulatory relevance of proposed CMC-changes
- Actively assess potential for upcoming new or updated regulatory guidance to impact on assigned scheduled submissions.
- It is essential you have strong communication skills - oral and written organizational skills and an understanding of drug development process in particular CMC- specific regulatory knowledge & experience.
- Typically requires a BA or BS degree in a relevant discipline and relevant experience in CMC Regulatory Affairs.
- Strong technical and regulatory writing experience.
- Able to manage multiple projects with competing deadlines.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jay Foster on +44 203 752 0309 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
#LI-JF1
Related jobs
US$180000 - US$210000 per annum + Highly Competitive Salary
Boston, USA
Proclinical is actively seeking a Director of Statistical Programming for a global biotechnology company. This is a permanent role with the opportunity to work remotely.
Highly Competitive
Brussels, Belgium
Proclinical is seeking a Professional Services Resource Manager. This role is pivotal in allocating resources to client projects.
Highly Competitive
Brussels, België
Proclinical are representing a medium sized, global biotech who are expanding rapidly due the significant products that are coming through in our clients pipeline.
Up to US$0.00 per annum + Highly Competitive Salary
Princeton, USA
Proclinical is seeking a talented and motivated Director of CMC for a leading biotechnology company located in Princeton, NJ.
Highly Competitive
Brussels, België
Proclinical has been retained by a cutting edge, biopharmaceutical company to appoint a Global Head of Quality for their commercial manufacturing sites.
Highly Competitive
Valais, Switzerland
Proclinical is seeking an Administrative Assistant to work a 12 month contract.
Highly Competitive Salary
Miami, USA
Proclinical Staffing is seeking an Associate Director, Access & Reimbursement - Oncology to join a global pharmaceutical organization.
Up to US$20 per hour + Highly Competitive Salary
Social Circle, USA
Proclinical Staffing is seeking a Warehouse Clerk to join a global pharmaceutical organization.
Highly Competitive
Leiden, Nederland
Proclinical is seeking a Senior Clinical Scientist to join our team. This role is integral to our development organization as we prepare to start clinical development of our Axiomer pipeline.
Highly Competitive Salary
Middletown, USA
Proclinical Staffing is seeking an Operations Manager, Chemical Manufacturing to join a leading healthcare organization.