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? 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

etc. to CDE and update in Merck’s system (Vault RIM) etc.

? Monitor regulation development and participants in local association activity if

necessary.

? May support on other regulatory projects such as ChP project registration project

etc.

? Support local business on daily basis request.

? Support Nantong plant projects include but not limited certificates maintenance,

regulatory assessment for change control 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 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.