上海招聘

职位描述：
Job Description

General Management
- Implements locally the Group RA policy, strategy and objectives as defined by the Head of Global Regulatory Affairs
- Manage the tasks for regulatory affairs, promotional material review on regulatory perspective and ensure artworks compliance in collaboration with related functions
- Supervise the China RA team and all related team management duties
- Provide the support to all partners as guided by general manager
 
Regulatory
- Drive drug & medical device registrations and variations in accordance with relevant regulations and develop the strategy to obtain the product approval within target timeframe
- Register and keep maintenance of foreign production sites
- Keep abreast of regulatory procedure and product changes to ensure products documents are maintained in compliance with local and corporate instruction.
- Effectively communicate and collaborate with Regional/Corporate RA and Pharmaceuticals team to develop Regulatory Strategies & to provide local regulation intelligence to internal stakeholders
- Maintenance of registration data base locally
- Maintain contact with regulatory authorities
- Support other general regulatory topics in collaboration with commercial

Compliance and Administrative Duties
- Ensure company's products comply with the regulations from regulatory perspective
- Plan and coordinate artworks changes with related department
- Validation of promotional material and packaging materials for compliance to local regulation and corporate policy.
- Perform annual review for compliance of local marketing material following corporate procedure
- Provide the support for province bidding and hospital listing process with close co-operation with sales team

Quality management
- Support the import control and general QA duties by internal procedures
- Coordinate the local product complaints with support of regional QA

Pharmacovigilance
- Support the China PV tasks as needed

Job Requirement
- Pharmacist or related academic background is preferred
- At least 10 years of relevant experience in pharmaceutical drug registration mainly and experience in medical device registration is preferred
- A good working knowledge of legal and regulatory issues
- Proficient in MS Office, including Word, Excel and PowerPoint
- Effective communication and interpersonal skills
- Detail-oriented and cross-functional team player
- Excellent verbal and written communication skills in English and Chinese
- Work precisely according to procedures, rules and regulations
- Recognize recurring issues and analyze their causes in order to reach a solution

自1926年起，加柏集团，这一医疗成像对比剂产品的研究开发领域的先驱者已经建立起了其悠久的传统。加柏公司总部位于法国巴黎，是一家上市公司，其在欧洲对比剂市场的市场份额为25%在全世界的市场份额为7%。

加柏充分利用其专业知识及创新能力，迎接21世纪公共卫生领域的重大挑战。

我们的团队为重大疾病（癌症，心血管、感染，神经变性疾病）的诊断技术进步做出了卓越的贡献。我们新型高效的成像解决方案为全世界的患者保证了更好的治疗方案。