Skip to main content

abbvie.com View Submission Status

Search jobs

Search jobs

About AbbVie

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.

Sr. Regulatory Affairs Manager

Beijing, Beijing Municipality, China Req ID 2210086 Category Regulatory Affairs Division AbbVie
Apply Now
  • 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
Apply Now
ABBVIE

Most recent jobs

Sign up for job alerts

Join our talent network and receive AbbVie news and job alerts to your inbox.

Interested InPlease select a category or location option. Click “Add” to create your job alert.

  • Regulatory Affairs, Beijing, Beijing Municipality, ChinaRemove

Our Terms of Use, Cookie Policy and Privacy Policy explain how we collect and use information about you and the rights you have. By submitting your information, you acknowledge you have read those documents and consent to receive SMS communications and email jobs alerts from AbbVie.

Recently viewed jobs

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application

Equal Employment Opportunity | Reasonable Accommodation