Specialist, Regulatory Affairs

Job Description

Coordinate, prepare, or review regulatory submissions for domestic or international projects.

• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
• Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
• Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
• Prepare or maintain technical files as necessary to obtain and sustain product approval.
• Coordinate efforts associated with the preparation of regulatory documents or submissions.
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.

• 3 year working experience with a minimum of 2 years experience required in Regulatory, R&D or related area
• Minimum of 1 years experience preferred in pharmaceutical regulatory affairs.
• Having experience interfacing with government regulatory agencies and proven skill at developing and implementing successful China regulatory strategies.
• Biologics experience a plus. Experience in Gastro, Liver, CV, Urology, CNS, Vaccine, etc. is a plus
• Fluent English both oral and written
• Working Computer Operation skill
• Is willing to travel
• Experience working in a complex and matrixed environment is required. Dependent on individual aptitude
• Up to date knowledge of legislation
• Self motivated

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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