南京招聘

Role Overview:

1. Familiar with relevant regulations and policies of drug or biologics registration; Responsible for consolidation of international and NMPA relevant regulations of drug/biologics and feed into the appointed projects;

2. Responsible for the registration strategy of all products in drug/device combination or biologics per China commercial’ business demand, to determine the key points of registration and manage the risk

3. Responsible for following up type testing, preparing submission documents, communicating with NMPA authority during technical evaluation period, conducting in compliance with local regulatory agency requirements and relevant SOP.

4. Responsible for good documentation management.

5. Responsible for providing regulatory support to relevant stakeholders, strong ability of drug registration information retrieval, analysis and research, Capable in Project management, analysis, problem solving and clear thinking

6. Responsible for establishment and maintaining a good communication with all internal stakeholders and external authorities/partners in the whole process of project research and development, reporting and approval process

Responsibilities: (Please specify % amount against each responsibility)

This is very important position to AWM product registration in China. Under that position, the staff needs to:

1. Set up the registration plan for AWM biologics or combination product projects according to commercial's launch plan, keep good communication with supervisor and co-worker, provide monthly update for the projects (20%);

2. Manage the whole process from project kick off to final approval for the NMPA registration, Organize periodic review of the project and guide the implementation of registration projects as planning; (40%)

3. Cooperate with China commercial, push the whole registration process going forward as planed following the SOP requirement. (20 %)

4. Set up good communication with internal and external stakeholders. (10 %)

5. Keep good documentation management for the assigned product projects. (5%)

6. Provide the regulatory support to other departments in daily work (5%)

Location: Beijing commercial

Education: Batchelor and above

Licenses/ Certifications:

Experience: 5 years or above registration experience in drug or biologics;

Competences:

Knowledge and experience on drug/biologics registration, Resilience, Agile, communication skill, interpersonal effectiveness, result driven, look into detail, custom focus etc.

Physical Demands:

Medicine, pharmacy, biochemistry, pharmacy management or other related fields, coming from pharmaceutical company is preferred.

Fluent English communication ability in listening, reading, writing and speaking

Team work spirits

Travel Requirements: 10–25%

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Smith & Nephew is a diversified advanced medical technology business that supports healthcare professionals in more than 100 countries to improve the quality of life for their patients.
 
We have leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma:
?    Orthopedics Reconstruction - joint replacement systems for knees, hips and shoulders
?    Advanced Wound Management - wound care treatment and prevention products used to treat hard to heal wounds
?    Sports Medicine - minimally invasive surgery of the joint
?    Trauma & Extremities - products that help repair broken bones

We have over 15,000 employees around the world. Annual sales in 2016 were more than $4.6 billion.
We are a constituent of the UK's FTSE100 and our shares are traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NYSE: SNN) .