Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Beijing, ChinaJob Description:
I. Registration
Plan: Well know assigned products' SP strategies, accurately and timely conduct SP strategy impact analysis and get alignment with BB RA, SC, MA, MKT, Global team and QA as needed, including aspects of RA Action, SC Restrication or not, inventory pre-build discussion, submission and approval timeline and so on. Understand when and how to ask supervisor's support to conduct SP strategy impact analysis accurately. Well understand the RAA (RA Actions) plans including Class I New Filing/Filing change; Class II/III PM Change, LM Change, IFU Filing and other registration change/filing; internal actions and so on according to the prioritization defined by supervisor; Correctly and approriately conduct timeline review and TAR as needed and aligned. know how to execute the plan by quarter/month/week/day; frequently track the implementation status.
Strategy: have basic sense on registration pathway, classification, timeline, review preference, can summarize and share the deficiency letter information with team and avoid the same deficiency items for the second time without strong justifications as informed. Regularly, and clearly communicate with Stakholders for different topics: With BB RA and Mkt to discuss General progress and Key projects status; With SC to discuss SC restricated products and Inverntory pre-build; With All for IFU CN draft according to SOP-09-025 process, and so on.
Execute: compile the registration dossier per most updated NMPA requirements; order sample and follow type testing if needed, to meet registration timeline; prepare eRPS submission and complete payment by due; closely track status in CMDE; handle reviewers questions and provide supporting documents per request; complete filling & database accurately input after approval.
II. Communication & escalation: clearly describe the questions/needs, timely ask WWBU RA for documents & support; Timely communicate with China cross function members on registration status; clearly communicate with reviewers on dossier contents; frequently communicate with supervisor to report progress. Well understand when and how to esclate to supervisors for help or attention, especially for tasks in risk to be on-target.
III. Post Market Compliance: Work together with BB RA team when needed, including but not limited to maintain related database accurately; execute routine after-approval processes e.g. Chinese labeling, copy review etc ; support post market actions e.g. audit, inspection, recall…
IV. Process Excellence: follow company SOP/WI/guidance on routine processes; think about improvement & speak out ideas.
V. Policy shaping: Curiosity and passion for new regulation, policy, standards and technologies; be aware of NMPA/CMDE/Lab common working processes; correctly interpret key regulatory requirements by self learning or participating training, and deliver to WWBU RA & other function members.
VI. build up basic self management skills, project management, time management, presentation, etc; good sharing & teaming spirit; actively absort knowledge from others & trainings
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Business Writing, Collaborating, Communication, Confidentiality, Data Reporting, Data Savvy, Detail-Oriented, Execution Focus, Legal Support, Medicines and Device Development and Regulation, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments