Regulatory Affairs Specialist

About this opportunity The Regulatory Affairs Specialist is responsible for implementing and maintaining local regulatory strategies. Responsible for supporting local regulatory strategies and accomplishing filings for product submissions and registrations, ensuring local regulatory requirements are communicated. This position reports to KR RAGAQA Sr...

About this opportunity The Regulatory Affairs Specialist is responsible for implementing and maintaining local regulatory strategies. Responsible for supporting local regulatory strategies and accomplishing filings for product submissions and registrations, ensuring local regulatory requirements are communicated. This position reports to KR RAGAQA Sr...

At Elanco (NYSE: ELAN) – it all starts with animalsAs a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy PurposeTM – to...

Job Responsibility Assists in filing and obtaining marketing approval from the MFDS for a planned new drug (K-NDA) and ensures subsequent maintenance of drugs registered (Supplemental & Amended K-NDA). Ensures quality filings of K-IND submission and its approval. Updates the assigned Local Product Documents (LPDs) in consistent with the local regulations...

Job Responsibility Assists in filing and obtaining marketing approval from the MFDS for a planned new drug (K-NDA) and ensures subsequent maintenance of drugs registered (Supplemental & Amended K-NDA). Ensures quality filings of K-IND submission and its approval. Updates the assigned Local Product Documents (LPDs) in consistent with the local regulations...

Job Responsibility Assists in filing and obtaining marketing approval from the MFDS for a planned new drug (K-NDA) and ensures subsequent maintenance of drugs registered (Supplemental & Amended K-NDA). Ensures quality filings of K-IND submission and its approval. Updates the assigned Local Product Documents (LPDs) in consistent with the local regulations...

:The RA specialist provides subject matter expertise and works with a team of regulatory affairs professionals to ensure that Beckman Coulter establishes best practices within the assigned area of responsibility (Product & site registration, Design change re-registration, PMS registration, Promotional material review, Regulatory advocacy, and, etc.).Key...

Key Responsibilities •Pharmacist support for PH. DDP business & local CoA. •Support quality/regulatory related matters to identify regulatory trends and their impact to the business to ensure that strategic business goals are met by sharing knowledge and expertise. •Develop or optimize regulatory technical packages to proactively help the Business...

Key Responsibilities •Pharmacist support for PH. DDP business & local CoA. •Support quality/regulatory related matters to identify regulatory trends and their impact to the business to ensure that strategic business goals are met by sharing knowledge and expertise. •Develop or optimize regulatory technical packages to proactively help the Business...

PURPOSE Sr. Medical Affairs Scientist (MAS) main role is to create and implement strategies, to build and develop enduring peer-to-peer relationships with healthcare professionals and institutions, creating constructive, cross-functional partnerships with internal and external stakeholders to generate customer insights and leverage business...

RA IND Specialist or RA IND Senior Specialist is responsible for getting IND approval in Korea within a planned timeline and taking the most appropriate actions to keep the clinical development in compliant with government regulations and company procedures including Good Regulatory Practice (GRP). Typical Accountabilities CTA/Product registration &...

Role description - Develops and implements pricing and reimbursement strategies for new products reimbursement/ reimbursement scope expansion to secure accelerated market access with optimal pricing - To minimize price erosion or access restriction due to various cost containment measures by the government. Typical Accountabilities - P&R dossier...

RA IND Specialist or RA IND Senior Specialist is responsible for getting IND approval in Korea within a planned timeline and taking the most appropriate actions to keep the clinical development in compliant with government regulations and company procedures including Good Regulatory Practice (GRP). Typical Accountabilities CTA/Product registration &...

Role description Develops and implements pricing and reimbursement strategies for new products reimbursement/ reimbursement scope expansion to secure accelerated market access with optimal pricing To minimize price erosion or access restriction due to various cost containment measures by the government. Typical Accountabilities P&R dossier development...

Role description - Develops and implements pricing and reimbursement strategies for new products reimbursement/ reimbursement scope expansion to secure accelerated market access with optimal pricing - To minimize price erosion or access restriction due to various cost containment measures by the government. Typical Accountabilities - P&R dossier...

Description Logistics Specialist Responsible for handling import/export and local transportation management for Korea. Job Overview： Work with and manage the Freight forwarders to setup shipments from overseas, be responsible for monitoring the shipment status, work with brokers for Customs clearance timely for the imported shipments in...

Key Responsibilities ·Korea REACH Coordinator, ·Daily regulatory compliance review and PSRA request handling ·SDS localization in Korea, ·Train the sales/Lab/office persons to have a clear mind of PSRA/HSE issues ·External authority’s coordination in terms of health, safety, environment, and chemicals. ·Regulatory information concerned...

Key Responsibilities ·Korea REACH Coordinator, ·Daily regulatory compliance review and PSRA request handling ·SDS localization in Korea, ·Train the sales/Lab/office persons to have a clear mind of PSRA/HSE issues ·External authority's coordination in terms of health, safety, environment, and chemicals. ·Regulatory information concerned Silicones...

Tax/Treasury SpecialistRequisition ID: 38921Job Location(s): Seoul, KRJob DescriptionDanfoss Global Services (GS) oversees operations in Finance, Real Estate, Indirect Procurement, and General Administration, prioritizing efficiency and scalability. As a key player in Danfoss, GS drives growth, ensures compliance, promotes digitalization, and leads energy...

REQ-25314Be an essential element to a brighter future.We work together to transform essential resources into critical ingredients for mobility, energy, connectivity and health. Join our values-led organization committed to building a more resilient world with people and planet in mind. Our core values ) are the foundation that make us successful for...