Regulatory Affairs Manager

Job Description:
The Regulatory Affairs Specialist is responsible for ensuring that work undertaken meets the requirements of government Regulatory Authorities in China, which necessitates the
submission of appropriate documentation to Regulatory Authorities prior to the performance of
clinical trials and again prior to marketing of a new pharmaceutical, biotech, or medical device
product for registration in China, as well as any maintenance tasks associated.
 
Responsibilities Include:
• Responsible for timely preparation/coordination of regulatory submissions for clinical trials
and market registrations for pharmaceutical, biotech, or medical device projects.  
• Works to high standards (governmental, Sponsor and GMCS) with minimal supervision.  
• Maintains awareness of current regulatory legislation, Guidance, and practice standards
related to drug and device submissions and clinical research.  
• Responsible for providing regulatory consultancy to client companies.
• Participates in project team planning, proposes registration plans, and ensures the  
implementation of these plans.  
• Serves as liaison between the client and Regulatory Authorities and  proactively interacts
with internal teams
• Evaluates the impact of clinical/regulatory changes on assigned projects.
• Reviews and approves deliverables prior to submission to clients and/or Regulatory
Authorities to ensure the compliance of deliverables to applicable regulations, guidance
requirements and client requests
• Develops and maintains documented regulatory procedures (SOPs) as required to assure
consistent and compliant regulatory activities
• Other relevant duties assigned for which the incumbent is qualified

Requirements  
• Bachelors degree, preferably in life sciences, with two years of experience in
Pharmaceutical or Medical Device industry or equivalent education and experience  
• A strong understanding of China and/or international Drug, Biologics or Device guidelines
and regulations
• Effective communication, planning, and organizational skills
• Ability to work in a team environment and be an independent self-starter, as required
• Must be able to meet deadlines and be detail oriented
• Proficiency in Microsoft Office (Word, Excel or Access, PowerPoint)
• Good command of English language and communication skills.