RA Manager
This vacancy has now expired. Please see similar roles below...
Proclinical is advertising a vacancy for a RA Manager position with a clinical stage biotech company. The organisation prides itself on its development of novel drugs that help reach unmet medical needs for patients. Based in the company's Beijing office, this is an exciting opportunity to work with a prestigious company and support their innovative impact on the scientific field.
The RA Manager will lead the regulatory strategy and be responsible to prepare and supervise all relevant documents for regulatory authorities for the company's phase I-III clinical studies.
Job Responsibilities:
- Familiar with CFDA, FDA relevant regulations, standards and guidance.
- Understand the regulatory pathway of the responsible products and select the appropriate regulatory pathway.
- Oversees CRO and compile registration dossier and ensure timely regulatory submission.
- Keep tracking the project registration process and resolve any issue timely to ensure earliest possible registration.
- Communicate with regulatory agencies/institutes on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.
- Build up and sustain a reliable and professional relationship with regulatory authorities (e.g., CFDA, CDE, Provincial FDAs) and other key players in the regulatory environment.
- Provide regulatory expertise to the R&D projects including biologics and small molecular drug products.
- Continuously monitor the development of regulations and policies of healthcare and pharmaceutical products and ensure the potential impact to clinical projects have been thoroughly evaluated and well communicated.
Skills and Requirements:
- BSc or Master's Degree in chemistry, pharmacy or related, or MD (licensed in the country, if applicable, according to local regulations).
- Min 5 years of experience in pharmaceutical industry or related industry like medical devices or healthcare industry.
- Good knowledge of written and spoken English.
- Good understanding of the Chinese and global regulations.
- 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 Kirsty Zhuang at k.zhuang@Proclinical.com 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-KZ1
#RegulatoryAffairs
Related jobs
Highly Competitive
Frankfurt am Main (60488), Germany
Proclinical are seeing a Clinical Application Specialist for a position based in Frankfurt.
£45000 - £55000 per annum
City of London, England
Proclinical are searching for a dedicated professional for a Senior Clinical QA Specialist (GCP).
Up to £0.00 per annum
Zürich, Schweiz
Proclinical are currently supporting is a global management and technology consulting group as they are looking to recruit a Senior SAP FI/CO Consultant in Zurich, Switzerland.
Highly Competitive
Crailsheim (74564), Germany
Proclinical are seeking a dedicated Technical Project Manager to lead software development projects in the medical technology field.
Highly Competitive
Zürich, Schweiz
Proclinical are recruiting for a Senior Software Developer Java to join a consultant. This role is on a permanent basis and located in Zurich.
Highly Competitive
City of London, England
Proclinical are searching for a Clinical Project Manager for a fully remote role within the UK.
Up to US$27 per hour + Highly Competitive Salary
Philadelphia, USA
Proclinical Staffing is seeking a Cell Manufacturing Associate to join a cutting-edge cell and gene therapy company.
Highly Competitive Salary
Rockville, USA
Proclinical is seeking a dedicated and innovative QC Microbiologist with a focus on endotoxin detection methods. This is a contract position located in Rockville, MD.
Highly Competitive Salary
Cambridge, USA
Proclinical is seeking a dedicated Talent Acquisitions Coordinator. This is a contract position located in Cambridge, MA.
Highly Competitive Salary
Wilmington, USA
Proclinical is seeking a dedicated Senior Quality Specialist to provide leadership and oversight on GMP operations related to clinical manufacturing.