Regulatory Affairs Specialist 药品法规事务(注册背景)

Regulatory Affairs Specialist
Location：Shanghai
MAIN PURPOSE OF JOB
Responsible for regulatory affairs of API/Excipient, especially on excipient, provide regulatory support to Life science business. Include but not limited, Work with global team and/or local agency/site to prepare regulatory submission documents for API/Excipient products, implement API/Excipient products registration/supplementary applications. Manage the registration project progress, make sure to meet the timeline. Monitor Drug/API/Excipient related regulation changes, evaluate the impact, provide regulatory guidance in risk assessment and recommendations to mitigate potential risk. Work as effective interface between company and authority/industry association (IPEC, CDE, NIFDC, Jiangsu MPA, etc.).
MAIN JOB DUTIES/RESPONSIBILITIES
• Coordinate with global regulatory counterpart to collect information required;
• Carry out all necessary work to ensure the efficient and timely submission for API/Excipient products, including new registration/ supplementary application/deficiency letter response/registration testing, etc. to CDE and update in system (Vault RIM) etc.
• Certificate application/maintenance/notarization and legalization: API Written Confirmation Certificate application, Food additive manufacture license and drug manufacture license maintenance, etc. Certificate notarization and legalization for export/import case.
• Support local business on daily basis request.
• Monitor regulation development and participants in local association activity if necessary.
• May support on other regulatory projects such as ChP project/IVD registration project etc.
EDUCATION AND LANGUAGE
• Major in Biological, Microbiological, Pharmaceutical or related academic background with bachelor’s degree or above.
• Chinese native & fluent English (verbal and written) are required.
PROFESSIONAL SKILLS AND EXPERIENCE:
• Experience of minimum 1-2 years in registration or regulatory affairs in pharmaceutical, biopharma or related Industry.
• Good regulatory knowledge of China laws and regulations in pharmaceutical including API/Excipient. Familiar with US and European regulations is preferred.
• Experience in API & Excipient registration area is preferred.
PERSONAL SKILLS AND COMPETENCIES:
• Ability to collaborate, management stress, and take initiative;
• A positive, can-do attitude;
• Good communication across multi-departments in multi- national cultures;
• Strong organizational, time management and project management skills.
• Ability to manage multiple priorities and deliver accurate outcomes.