Regulatory Management

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginablewith us.

**Your Role**

**What You Do**

Operational Excellence:

- Focal contact point to customs authorities, freight forwarders, customs broker, foreign affiliates, on import and export compliance requirements to resolve day-to-day issues that may result in customs clearance delays
- Manage HS code classification, product review against regulatory/trade requirements.
- Review of customers sales orders and intercompany purchase orders in Global Trade Services
- Maintenance of business import/export permits, annual licenses, IVD medical device product registration/licences to minimize supply chain disruption
- Manage regulatory audits, reporting, record keeping of documentation, ensuring compliance with all relevant regulations for import, export, sale, storage of chemicals
- Manage validation of new customers, sanctioned party list screening and verification of end-user statements and customer licences
- Provide advice and guidance for import/export activities to Commercial, Product Management, Customer Excellence, Supply Chain and Distribution
- Support regulatory & quality expertise and consultation for customer regulatory inquiries.

Process Optimization:

- Build up and facilitate GTS (global trade service) system, integrate import/export and domestic trading requirements into the order screening process, to ensure transactional compliance.
- Perform periodical internal audit, periodical review of trade compliance processes, identify compliance process gaps, understand criticality of gap, and build a roadmap for improving compliance controls, design of process changes to implement business controls.
- Monitor and report on changes of relevant regulatory and compliance environment with impact with the Life Science business. Analyze available regulatory and compliance information and define processes to implement upcoming regulatory needs and requirements.
- Drive and develop digitalization strategy and automation tools to improve efficiency and improve data quality.
- Identify opportunities for process efficiency and effectiveness in compliance through automation or process improvement, put in place compliance-related metrics and a program for continuous improvement.

Strategy:

- Proactively contribute to trade compliance initiatives / projects in APAC region. Keep close interaction & collaboration with APAC country TC SMEs and global trade compliance organization in Americas and Europe.

**Who You Are**
- Degree/Master/PhD in Life Sciences, Chemical, Pharmaceutical, Biomedical related discipline, Law, International Trade or related area.
- Experience of 4 years or more as a regulatory and or trade compliance function in life sciences industry, good knowledge in life science products
- Knowledge in regulations for import/export, sale and storage of chemicals
- Knowledge in medical device, pharmaceutical and biopharmaceutical regulatory framework, eg cGMP, FDA, EMA, ISO standards.
- Experience in working with local controlling agencies on import/export customs requirements, licences and IVD medical devices registration
- Basic Knowledge in SAP system eg GTS
- Proficient in MS Office Applications especially MS Excel and any other digital tools
- Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels.
- Strong organizational, analytical and time management skills.
- Able to work independently and takes initiatives
- Ability to manage multiple priorities and deliver accurate outcomes.

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress