Job Information
Sartorius Regulatory Affairs Specialist in Shanghai, China
As part of the Regulatory Affairs team, the Regulatory Affairs Specialist enables the adoption and use of biotechnology products, including single use technologies, filtration devices for medical, food & beverage and drinking water applications and products for advanced therapies and cell culture media. This is achieved by supporting R&D, Engineering, Sales, Supply Chain, Marketing, and other internal functions on issues related to quality and regulatory compliance.
The ideal candidate will advise project teams on subjects such as customer requirements, material compliance, labeling requirements, shelf life, registration, permits and sterility to assure products meet requirements for global sale.
The Regulatory Affairs Specialist also provides support to customers requesting regulatory and quality documents for product approval. The regulatory focus will be on the Asia market with the major applications: Food Contact Materials, Drinking Water, Equipment/Systems for Pharma and Medical Devices.
The Regulatory Affairs Specialist will be responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements. The holder of this position will organize regulatory information and is able to interpret regulations for relevant stakeholders, collate track and control submissions and provide guidance and advice to internal stakeholder.The holder of the position will be responsible as the contact for the authorities.
Main Responsibilities & Tasks:
Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
Provide expert regulatory input to strategic decision making; including review, prioritization, and external communications
Support the development and establishment of procedures, policies and standards
Coordinate successful submissions and approval of applications
Plan, undertake and oversee regulatory inspections
Liaise and negotiate with regulatory authorities
Provide advice about regulations to relevant stakeholder
Review and report overall quality status
Keep up to date with changes in regulatory legislation and guidelines
Qualifications & Skills:
Bachelor’s degree in a science or related field
5+ years relevant experience within the Regulatory Affairs discipline
Deep knowledge of the relevant Regulatory requirements for devices/products listed above
Thorough understanding and demonstrated ability to apply Regulatory guidelines/regulations
Ability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources
Proven analytical skill and technical/scientific competence
Attention to details and ability to appropriately assess risks
Strong initiation and organizational skills
Excellent communication skills, with ability to influence others and negotiate successful outcomes
Proactive, quick learner and independent worker able to effectively multi-task in a strongly growing organisation
Team-player, able to positively influence Team members at all levels
Fluent in English
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application. www.sartorius.com/careers
to our Candidate Portal and thank you for your interest in working and growing with us. We look forward to receiving your application. You can check the status anytime in this portal.
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Information on the application process can also be found in this video and under FAQ & Contact (https://www.sartorius.com/en/company/careers/faq) .
In this brochure (https://www.sartorius.com/resource/static/celum/202114/23_EN_Candidate_Booklet_Digital_web.pdf) you will learn more about us as an employer and your career with us. For further insights, please visit the Sartorius Blog (http://www.sartorius.com/en/company/newsroom/blog) and our career website (http://www.sartorius.com/en/company/careers) .
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