Job Description
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Responsibilities
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.
Qualifications
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
Additional Information
AbbVie 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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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