公司介绍
AbbVies mission is to discover deliver innovative medicines solutions that solve serious health issues today address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas – immunology, oncology, neuroscience, eye care – products services in our Allergan Aesthetics portfolio. Follow on X, Facebook, Instagram, YouTube, LinkedIn Tik Tok.
职位描述
Purpose
Describe the primary goals, objectives functions outputs of this position.
Coordinate, prepare, review regulatory submissions fdomestic international projects.
Responsibilities
List up to 10 main responsibilities fthe job. Include information about the accountability scope.
- Provide technical review of data reports that will be incorporated regulatory submissions to assure scientific rigor, accuracy, clarity of presentation.
- Review product promotional materials, labeling, batch records, specification sheets, test methods fcompliance with applicable regulations policies.
- Maintain current knowledge base of existing emerging regulations, standards, guidance documents.
- Interpret regulatory rules rule changes ensure that they are communicated through corporate policies procedures.
- Determine the types of regulatory submissions internal documentation that are required in situations such as proposed device changes labeling changes.
- Advise project teams on subjects such as premarket regulatory requirements, export labeling requirements, clinical study compliance issues.
- Prepare maintain technical files as necessary to obtain sustain product approval.
- Coordinate efforts associated with the preparation of regulatory documents submissions.
- Prepare direct the preparation of additional information responses as requested by regulatory agencies.
职位要求
Qualifications
List required preferred qualifications (up to 10). Include education, skills experience.
- 3 year working experience with a minimum of 2 years experience required in Regulatory, R&D related area
- Minimum of 1 years experience preferred in pharmaceutical regulatory affairs.
- Having experience interfacing with government regulatory agencies proven skill at developing implementing successful China regulatory strategies.
- Biologics experience a plus. Experience in Gastro, Liver, CV, Urology, CNS, Vaccine, etc. is a plus
- Fluent English bothal written
- Working Computer Operation skill
- Is willing to travel
- Experience working in a complex matrixed environment is required
Dependent on individual aptitude
- Up to date knowledge of legislation
- Self motivated
额外信息
AbbVie is an equal opportunity employer is committed to operating with integrity, driving innovation, transforming lives serving our community. Equal Opportunity Employer/Veterans/Disabled.
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