长沙招聘

Job content (purpose of the job)
Key areas of responsibility:
Regulatory Planning
Submission and Approvals of New Products and Marketed Products Maintenance
Regional Regulatory Affairs
Regulatory Compliance
Coach the Junior Employees
Regulatory Influence
Cross Function/Department Supporting

Main job tasks:
Regulatory Planning
Regulatory Strategy Development
Development of the Implementation Plan that is aligned with the business need.
Process Management
As the project manager during the registration stage (CTA and NDA）, make the strategic and competitive plans for the regulatory process, lead the whole project team to approach the key milestones according to the plan and manage the communication and escalation pathway in a consistent manner.
Coordinates the process with other functional members of the affiliate and HQ to ensure timely availability of required documents and samples, if appropriate.
Active participation in project teams during the clinical trial implementation within the affiliate and provide regulatory expertise and insight to ensure regulatory timelines are met or improved.
Regulatory Tools
Timely update of data in RIMS (Regulatory Information Management System) according to the timeline of CARL (Co-ordinated Actions to Reduce Lead-time – Project).
Ensure the data in RIMS is accurate, complete and aligned among projects.
Submission and Approvals of New Products and Marketed Products Maintenance
Submission and Approvals of New Products
Dossier Preparation
Prepare a quality regulatory dossier and submit within the planned timelines. Activities include:
Request, obtain and evaluate the various regulatory items needed for the local submission.
Prepare/format the dossier to ensure it meets local requirements.
Implement the submission and archive appropriately.
Drug test:
Request, obtain and submit timely the drug samples, reference substance and equipment needed for the drug test.
Proactively communicate with and respond to the technicians of drug control institutes before and during the drug test to make the process smoothly.
Get the COA and/or specification to be delivered to the Center of Drug Evaluation (CDE) timely.
Gain Regulatory Approval
Gain the approvals to meet the product launch plans and ensure product maintenance. Activities include:
Communicate and negotiate with the Health Authorities (HA) proactively, efficiently and timely.
Complete regulatory approval process and gain product licences.
Communicate the approval with HQ, the related functions within BAC and NNTP timely to ensure the planned launch.
Archive submission dossier and approval documents.
Perform regulatory responsibilities related packaging development, and ensure the local label creation and packaging development will meet local and corporate criteria and supports the business needs.
Support the following pricing, reimbursement and bidding efficiently and timely.
Marketed Product Maintenance
Take appropriate actions to maintain all local marketed products in compliance with local and corporate regulatory requirements including manufacturing or labeling (insert and packaging) variations, renewals, repackaging and deregistration.
Communicate timely with HQ, the related functional members within BAC and NNTP to ensure the product supply.
Regional Regulatory Affairs
Support HK to get the approval of new drug application, variation, renewal and deregistration.
Regulatory Compliance
Accept corporate compliance audit to identify potential compliance issues;
Take corrective actions plans based on regulatory audit findings;
Develop, update and implement appropriate SOPs.
Coach the Junior Employees
Regulatory Influence
External
Regulatory Customer Relations
Build good relationships with key regulatory officials (throughout direct interactions, industry associations, opinion leaders programs, etc.) to influence regulators to achieve positive outcomes for NN’s product approvals or industry advantages.
Regulatory Environment Changes
Keep updated with current local regulations and HA organisational structure and potential changes that will impact the business environment, and communicate appropriately to involved or affected parties.
Influence on the Regulations
Active comments on the regulations to influence HA.
Internal
Affiliate Organisation:
Learn and understand the local affiliate organisation and functions.
Regulatory Value:
Proactively communicate with the affiliate business partners of the global regulatory status of new products and local regulatory trends that may impact the business.
Educate the affiliate the value that the regulatory function can significantly contribute to the business.
Cross Function/Department Supporting:
Technically supports for HE, GA and COM with regulatory expertise and insight.
Provide quality regulatory support for locally manufactured products
Provide regulatory support for locally performed clinical trials (i.e. gain CT approval; CT material labelling, CT licence, etc…)

Qualifications:
(minimum requirements)
Good understanding of the Chinese and global regulations
Competent project management skills
Good team working and experience sharing;
Ability to handle multi-task activities
Good oral/written communication & interpersonal skills
Ability to handle conflict; initiative and negotiation skills
Skill of communication with internal customers
Analytical skills: accuracy, reliability
Creative thinking and problem solving
Education:
Relevant graduate level degree, e.g. Pharmacy, Pharmacology, Biology.
Fluency in both written & spoken English.
Professional experience:
Min 3+ years experience in RA area in pharmaceutical industry or related industry like medical devices or healthcare industry;
Have or acquire in-depth knowledge of local regulations pertaining to product registration requirements for pharmaceutical products and devices, skill of project management
Have or acquire overall understanding of the local business decision-making process that impacts the regulatory strategy.
Skill of communication and argument with HA.

Supplementary job description:
Degree of independent decisions:
Authority to decide and act on decisions that impact the project registration, such as technical communication with CDE and administration process follow up with SFDA, roughly 60% of independent decisions can be made in this position.
As the project manager of CPU (Clinical Project Unit), has the ultimate authority to lead the CPU and set up request & follow up actions.
Level of innovation:
Innovation and initiative is required to develop the registration work by continuously improving methods, techniques and communication.
Main stakeholders:
Internal: Marketing & Sales, Commercial, Production, CRM/CRA and HQ RA
External [country]: HA officials and professionals, Pharmaceutical association
Degree of influence on departmental / function / NN results:
Influence on RA results.
Communication / Interaction with others internally or externally:
Communication and interaction with both internal and external stakeholders
Managing relationships with local stakeholders requires a range of communication approaches, e.g. presentations, meetings and negotiations
Describe the scope of the job in terms of working away from the home country :
App. [90]% of the job is performed in [China]
App. [10]% travel abroad for congresses, seminars or meetings

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