• 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.

• 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.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.