Sr Regulatory Affairs Specialist
Sr Regulatory Affairs Specialist
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Job Description
Purpose
Describe the primary goals objectives or functions or outputs of this position.
Coordinate prepare or review regulatory submissions for domestic or international projects.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
- 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 serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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US & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
