Similar posts
Contractor, Global Regulatory CMC
This vacancy has now expired. Please see similar roles below...
A major biotechnology company is advertising a vacancy for a Contractor, Global Regulatory CMC position. With an extensive pipeline and commercial portfolio in oncology and immunology, this organisation is offering an exciting opportunity to join their team in Uxbridge. The successful applicant will have the chance to marry their expertise to an internationally renowned company and support their innovative impact on the healthcare field.
Job Responsibilities:
- Participating in the development of the CMC regulatory strategy for submissions with an emphasis on international regions. These submissions include CTA/MAA regulatory filings.
- Collaborating with Regulatory CMC project leads and other relevant line functions to prepare CMC submission documents, registration dossiers, and responses to health authorities for responsible regions.
- Participating in the regulatory evaluation of CMC change controls by liaising with Regulatory CMC project leads and Regulatory Affairs International to determine regulatory impact for responsible regions.
- With supervision, managing Regulatory CMC activities related to commercial compounds for responsible regions.
- Representing Regulatory CMC on Regulatory Affairs International teams.
- Participating in document review meetings and discussions for responsible regions.
- Developing an internal knowledge base for CMC international activities including submission document requirements and working practice for interacting with country affiliates.
Skills and Requirements:
- Experience with CMC regulatory documents (variations, responses and CTAs) and with registration dossiers for worldwide use.
- Knowledge of ICH guidelines and CMC regulations for international regions.
- Experience in developing global CMC regulatory strategy.
- Experience in managing post approval Regulatory CMC activities globally.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Numhom Sudsok at +44 203 871 8093 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-116605466_NS1
#RegulatoryAffairs
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.