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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

(Junior) Project Manager Regulatory Affairs (all genders) - (unlimited / fulltime)

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany Req ID 2210848 Category Regulatory Affairs Division AbbVie
  • 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 requiredDependent on individual aptitude
  • Up to date knowledge of legislation
  • Self motivated

Travel: Yes, 10 % of the Time
Job Type: Experienced
Schedule: Full-time
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