Prepare, review, and submit regulatory dossiers, registrations, amendments, renewals, and variations.Maintain regulatory databases, product registrations, licenses, and archives.Support product lifecycle management activities, including change assessments and regulatory impact evaluations.Review product labeling, IFUs, packaging, and promotional materials for regulatory compliance.Monitor global regulatory requirements and communicate regulatory changes to stakeholders.Coordinate responses to health authority queries and regulatory inspections.Collaborate with Quality, Clinical, R&D, Medical Affairs, Supply Chain, and Marketing teams.Track submission timelines, approvals, renewals, and compliance metrics.Support regulatory strategy development for new product launches and market expansions.Participate in risk assessments, CAPA activities, and compliance improvement initiatives.
Key Responsibilities
Prepare, review, and submit regulatory dossiers, registrations, amendments, renewals, and variations.Maintain regulatory databases, product registrations, licenses, and archives.Support product lifecycle management activities, including change assessments and regulatory impact evaluations.Review product labeling, IFUs, packaging, and promotional materials for regulatory compliance.Monitor global regulatory requirements and communicate regulatory changes to stakeholders.Coordinate responses to health authority queries and regulatory inspections.Collaborate with Quality, Clinical, R&D, Medical Affairs, Supply Chain, and Marketing teams.Track submission timelines, approvals, renewals, and compliance metrics.Support regulatory strategy development for new product launches and market expansions.Participate in risk assessments, CAPA activities, and compliance improvement initiatives.
At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first.
HCLTech is a global technology company, home to more than 223,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending June 2026totaled $14.8billion.
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Senior Technical Lead in Zuchwil Arbeitgeber: HCL Technologies Limited
HCLTech ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Ludwigshafen eine dynamische und unterstützende Arbeitsumgebung bietet. Mit einem starken Fokus auf persönliche Entwicklung und Karrierewachstum profitieren die Mitarbeiter von umfangreichen Schulungsprogrammen und der Möglichkeit, an innovativen Projekten in einem globalen Team zu arbeiten. Die Unternehmenskultur fördert Zusammenarbeit und Kreativität, während attraktive Benefits und ein modernes Arbeitsumfeld sicherstellen, dass sich jeder Mitarbeiter wertgeschätzt und motiviert fühlt.
