Lead Regulatory & Compliance Specialist at Danaher Corporation

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Biotechnology, DiagnosticsIndustries

Requirements

Solid experience in drug registration and participation in IND, BLA, NDA, and the drug modification process
Experience in GMP inspection and involvement in the drug production process
Understand the application of the products from Cytiva
Proficient in English
Willingness to travel up to 50%

Responsibilities

Perform pharmaceutical-relevant regulatory topics presentations in public occasions (including industry conferences, customer sites, etc.) on Cytiva’s regulatory positioning
Direct participation in local customer projects discussion & design (cooperate with the local commercial team for projects)
Shaping the connection between the regulatory authorities and Cytiva in multiple ways, including Industrial Conference, GMP Inspectors Training, Thematic Research, etc
Support the local commercial team on internal training as organizer & trainer
Support internal cross-linked activities and projects (including resources coordination/meetings preparation etc.) between commercial and regulatory teams
Support internal initiatives as required by the QARA team
Provide analysis, counsel, regulatory support, quality assurance, environment, health and safety, facility security, and emergency response services, and regulatory and compliance technical training services to the organization

Skills

Regulatory Compliance

Quality Assurance

GMP

Pharmaceutical Regulations

EHS

Regulatory Training

Customer Project Management

Industry Presentations

Danaher Corporation

Water quality, diagnostics, and identification solutions

About Danaher Corporation

Danaher Corporation operates in key markets such as water quality, product identification, and diagnostics. The company provides precision instruments and advanced purification technologies for analyzing and managing water, ensuring its safety in various environments. In product identification, Danaher specializes in laser marking, coding, and packaging solutions that help maintain product freshness and accurate labeling throughout the supply chain. In the diagnostics sector, Danaher offers tools and software that enhance diagnostic confidence, enabling healthcare providers to deliver effective care. What sets Danaher apart from competitors is its unique Danaher Business System, which focuses on continuous improvement and empowers employees to drive change. The company's goal is to consistently deliver high-performance products and solutions while maintaining leadership in its markets.

Washington, District of ColumbiaHeadquarters

1969Year Founded

IPOCompany Stage

Industrial & Manufacturing, Healthcare, Consumer GoodsIndustries

10,001+Employees

Risks

Increased competition from Roche and Abbott in AI-driven diagnostics.

Potential regulatory challenges in the EU for water quality sector.

Supply chain vulnerabilities affecting precision instruments sourcing.

Differentiation

Danaher's Danaher Business System drives continuous improvement and superior financial performance.

The acquisition of Cytiva enhances Danaher's capabilities in the biopharmaceutical sector.

Danaher's advanced purification technologies meet increasing demands for sustainable water management.

Upsides

Danaher's investment in AI-driven healthcare solutions boosts its diagnostics capabilities.

Cytiva acquisition expands Danaher's market share in the biopharmaceutical sector.

Point-of-care testing demand drives growth for Danaher's diagnostic tools and software.

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