EM&S Quality Regulatory Manager - China
No salary listed
Senior
Master's
Shanghai, China
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)
About the job
Requirements
- A master's degree or higher in Pharmacy, Chemistry, Biology, Biochemistry, or a related major.
- At least 5 years of practical experience in pharmaceutical production and quality management, including at least 3 years of practical experience in sterile drug production and quality management.
- Familiarity with GMP regulations such as NMPA and EMA, ICH guidelines and requirements, and relevant MAH system provisions; professional knowledge of biological product quality and production management, quality control, and product production processes.
- Good inspection management, analytical, and problem-solving abilities.
- Up-to-date understanding of industry technologies and regulations.
- Sufficient judgment and influence to make decisions that ensure patient safety and protect the company's reputation.
- Good English skills.
Responsibilities
- Establish and maintain the contract manufacturing Quality Management System in accordance with pharmaceutical regulatory requirements.
- Establish the self-inspection system, monitor implementation of relevant quality management systems, and maintain self-inspection records.
- Manage quality risk communication and review.
- Conduct quality management reviews, define quality metrics, visualize compliance performance, and drive continuous improvement.
- Liaise with health authorities on product permissions, GMP, tender certificates, and other certifications.
- Apply for manufacturing licenses, product permissions, and other certificates as required by business needs.
- Ensure operations comply with current laws, regulations, and internal policies; complete annual product quality and drug reports and submit required updates to regulatory authorities.
- Coordinate regulatory authority inspections, lead external audits, and ensure timely submission of corrective and preventive action plans.
- Build and maintain the change control system, ensuring effective procedures guide change risk assessment and minimize compliance and product quality risks.
- Ensure effective implementation of post-marketing product change control and evaluate and manage risks from changes to entrusted products.
- Implement and close corrective and preventive actions for regulatory changes.
- Maintain the regulatory database.
- Prepare department standard operating procedures and maintain related records.
- Establish and maintain the training system, including the training matrix and annual GMP refresher training.
- Review and approve packaging material artwork according to regulatory requirements.
- Coordinate across functions regarding regulatory changes, new implementations, and artwork improvements.
- Establish and maintain the supplier management system, including supplier evaluation and approval, quality agreement management, and supplier change management.
- Support on-site inspections of major material suppliers' Quality Management Systems.
- Work on-site at the contract manufacturing enterprise during entrusted drug manufacturing and provide on-site guidance and supervision over production and quality management to ensure processes and standards meet regulatory requirements.
- Quarterly evaluate the contract manufacturing organization's Quality Management System to ensure it meets contractual standards and Quality Assurance Agreement obligations, and that both parties' systems integrate effectively.
- Coordinate with cross-functional teams to prepare regulatory documents for submissions or other applications to health authorities, and participate in stakeholder-organized meetings.
- Review Pharmacopoeia changes affecting the EM&S China product portfolio and develop implementation action plans.
- Make quality decisions as a delegate of the quality responsible person (QP) when necessary.
- Complete other tasks assigned by the manager.
Desired Qualifications
- Experience operating under the MAH (Marketing Authorization Holder) system.
About the company
Sanofi is a global pharmaceutical and biotechnology company that develops, manufactures, and sells prescription medicines, over-the-counter products, and vaccines. Its products span immunology, oncology, rare diseases, and vaccines, addressing unmet medical needs through a strong focus on research and development. Sanofi's core product model relies on large-scale R&D, strategic partnerships, and licensing to bring new therapies to markets, with revenue generated from product sales and collaborations. The company differentiates itself by leveraging its global reach, diverse portfolio, and emphasis on patient-centric solutions, safety, and quality to navigate regulatory environments in developed and emerging markets. The company’s goal is to improve health outcomes and quality of life for people worldwide by delivering innovative treatments and vaccines that meet unmet medical needs.
Company Size
10,001+
Company Stage
IPO
Headquarters
Paris, France
Founded
1973
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Simplify's Take
What believers are saying
- July 10, 2026 FDA approval of Sarclisa Escena created the first on-body cancer injector.
- June 13, 2026 FDA accelerated approval expanded Tzield into recently diagnosed stage 3 T1D.
- Q2 2026 sales grew 17.8% at CER, with Dupixent and Beyfortus leading.
What critics are saying
- Texas sued Sanofi on February 19, 2026 over provider bribery and Medicaid fraud.
- Sanofi sued Pfizer and Moderna on July 15, 2026, extending costly mRNA patent warfare.
- Dupixent concentration makes 2030s patent loss an existential revenue shock.
What makes Sanofi unique
- Dupixent reached €5.2 billion quarterly sales in Q2 2026 across nine indications.
- October 1, 2026, Sanofi and Regeneron added four long-acting antibodies to their Alliance.
- Sanofi's 61-project pipeline spans immunology, rare diseases, vaccines, neurology, and oncology.
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Benefits
- Health Insurance
- Professional Development Budget
- Parental Leave