Regulatory Affairs Manager
AbbVieBeijingUpdate time: July 22,2021
Job Description
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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Develop regulatory strategies, plans and timelines, to ensure successful new registrations and effective product maintenances, in line with local business objectives.Manage regulatory submissions process, prepare high quality submission packages and responses to deficiency questions within applicable timelines.Work closely and swiftly with cross-functional and brand teams to update regulatory projects, address critical issues and potential solutions. Provide regulatory advices and supports to business personnel, including tender.Review labeling, promotional and educational materials to ensure compliance.Monitor and forecast regulatory environment periodically, and assess impact to AbbVie business. Liaise with drug authorities for insights into current activities and future direction of regulation.Develop and maintain regulatory operation processes and systems to support regulatory submissions and approvals in the most efficient.Develop and manage product registration database to ensure information transmission timely and accurately. Develop, compile and update local SOP on quality management systems, quality accountabilities and working methods.Handle non-medical complaints according to local SOP.Manage cold chain according to global SOP. Conduct management review quarterly.Update package inserts, corresponding overlabels and finished product labels, ensure reviews and approvals in a timely manner.Review and release finished products with proper labeling. Develop and manage product quality database to ensure information transmission timely and accurately.Lead audit activities for QA/RA functions as required.Support PV audit. Qualifications Education:Bachelor degree or above in pharmacy or related science. Master degree is preferred.At least 5 years regulatory affairs experience in pharmaceutical or biotech industry.Working experience with multinational company.Experience with new chemical entities (NCE), biologics and clinical trial application.Familiar with regulatory guidelines and requirements.Project management skill. Adaptability:Try to understand changes.Treat changes and new situations positively.Adjust behavior to deal with changes. Initiative:Respond quickly & being proactive.Implement new ideas or potential solutions without prompting.Take action that goes beyond job requirements in order to achieve objectives. Integrity:Maintain, promote social & ethical norms.Adhere to codes of conduct & ethical principles. Innovation:Generate innovative solutions in work situations.Draw multiple sources for ideas and inspiration.Try different & novel ways to deal with work problems. Teamwork:Share important or relevant information with the team.Listen to & fully involve others in team decisions & actions.Establish & maintain good working relationships with others. Work Standard:Set standards for excellence.Ensure high quality.Take responsibility. Travel Yes, 5 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.

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