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Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) .

Job Description

Product registration • Take over related registration work to achieve and new product approval in China and license maintenance if applicable. Including: a. Define regulatory strategy including clinical pathways for assigned products, including kinds of meetings with global team and local cross-functional meeting b. Compiling product technical requirement for assigned products based on related industry standard and technical file from global company, and order samples to follow up type testing c. Document preparation based on NMPA requirement and submission to NMPA d. Regulatory input for clinical evaluation/trial if necessary; Involve the discussion on protocol and clinical study report, etc. if needed. Support the GCP inspection if applicable e. Follow up evaluation and solve other problems during registration f. Keep record for all related documents during registration through approval process g. Chinese IFU and labeling maintain to make sure comply with NMPA regulation h. Support Hainan application for commercialized activities if needed i. Support GMP inspection if applicable • Necessary involvement with crossing functional communication, such as product launch plan, registration budget forecast for assigned products and projects and make sure the information is consistent and correct. 2) Monitor the Chinese and international Medical Device regulatory change and update, and provide China and global teams with assessments of the impact of new and changing Chinese regulations on the company business. 3) Being proactive to participate industry activities and trainings to contribute construction suggestions. 4) Assure that all post-approval and Quality Systems requirements are met to maintain required registrations and licenses, in cooperation with Quality Assurance. 5) Assist QA to cooperate post market surveillance and recall if there is. 6) Monthly report or other regular update on assigned projects and products.

Qualifications

• Formal Education/Training • University degree (B.A., B.S., M.S.) or equivalent in pharmacy, pharmacology, chemistry, medicine, engineering or the biological sciences is required. • Fluent in both Mandarin Chinese and English. 5. Experience • At least 6 years of experience in Medical Device Regulatory Affairs is required, with experience in managing major projects. Mixed experience on implantable medical device and electronic equipment is preferred. • Hands-on experience and scientific and technical background/training in regulatory submissions. • Successful track record of working in a matrix organization with other functions including global team, clinical affairs, MKT, R&D, manufacturing etc. 6. Knowledge, Skills, and Abilities • Time management on several parallel projects. • Strong learning desire and still on new application, read technical files. • Ability to share within and outside the team. • Thorough knowledge of NMPA regulations and requirements. 7. Travel • Travel is needed if necessary to commit the registration target.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. 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 protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html