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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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Sr. Regulatory Affairs Manager

Beijing, Beijing Municipality, China Req ID 2210086 Category Regulatory Affairs Division AbbVie
  • Manage regulatory submissions process and their compliance with regulation, prepare high quality submission packages and responses for clinical trials, new product license applications and variations, annual updates within applicable timelines
  • Monitor and influence assessment process to expedite and optimize the outcome of their submissions, to ensure submissions are made in accordance with accepted regulatory standards within appropriate timeframes.
  • Lead, maintain and develop communication with Regulatory Authorities and Regulatory consultants, drive negotiations to ensure best possible product labeling and delivery of their commitments and deadlines
  • Proactively build relationships externally and internally, work closely and swiftly with cross functional teams to address critical issues
  • Communication of any regulatory changes to the business as necessary
  • Creation, submission and maintenance of official local drug information, including Patient Information Leaflets, and packaging texts.
  • Ensure promotional activities are compliant to relevant legislation, implement and ensure systems are established and maintained for Regulatory Affairs Document Management.
  • Participate in safety reviews for implementing appropriate safety updates, lead audit activities for regulatory function as required

  • Industry experiences: A minimum of 5 years experience required in Regulatory, R&D or related area
  • Position experiences: Minimum of 3 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
  • Language Skills:Fluent English both oral and written.
  • Computer Skills:Highly Computer literate
  • Mobility: Is willing to travel
  • Other Special requirements:Experience working in a complex and matrixed environment is required.Dependent on individual aptitude with experience of a broad range regulatory work in the ethical pharmaceutical industry.Management experience.Up to date knowledge of legislation.
Travel: No
Job Type: Experienced
Schedule: Full-time

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