Similar posts
China RA Head
This vacancy has now expired. Please see similar roles below...
An international biotechnology company is looking to recruit an RA Head to their office in Shanghai. The organisation specialises in maximising the development and commercialisation of enabling products and technology from oncology in the greater China markets.
Job Responsibilities:
- Assist to develop and implement regulatory strategies.
- Provide regulatory advices and risk assessments on products to regulatory affairs director.
- Make regulatory plans and ensure fast registration approval, in line with regulatory requirements and China business objectives.
- Achieve successful submissions for pipeline products to regulatory authorities.
- Manage whole regulatory submissions process including dossier preparation with high quality, timely responses to deficiency questions and efficiently resolve technical issues from QC test for all applications within planned timelines.
- Work closely and swiftly with functional department to update status of regulatory projects and share solutions for potential issues.
- Provide competitors registration status to functional department.
- Intelligence: monitor and forecast regulatory environment and intelligence news periodically, and assess impact to company business, if any critical news, alert team timely.
- Lead team discussion on critical regulation/guidance.
Skills and Requirements:
- Demonstrable experience in a similar role or capacity.
- University degree preferred.
- 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 Stephen Qin at +86 21 51694107 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-SQ1
#RegulatoryAffairs
Related jobs
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.
Highly Competitive Salary
Zebulon, USA
Proclinical Staffing is seeking a Chemist to join a global leading pharmaceutical company.
Up to US$40 per hour + Highly Competitive Salary
Boston, USA
Proclinical Staffing is seeking an In-Vitro Research Associate to join a leading pharmaceutical company.
Highly Competitive Salary
Philadelphia, USA
Proclinical Staffing is seeking a Clinical Research Nurse to join a top medical program.
Highly Competitive Salary
Philadelphia, USA
Proclinical is seeking a Grants Manager A to join a cutting-edge medical program.