Senior Regulatory Science Specialist

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...

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...

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 &...

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 &...

: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...

Essential Functions • With moderate oversight and supervision, werve a Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project...

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...

Senior Clinical Research Physician (Senior Clinical Research Medical Manager), GCF 6We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules as well as Other therapeutic area, Cardiology and Inflammation – and we need top talent to ensure these molecules become medicines and...

Senior Clinical Research Physician (Senior Clinical Research Medical Manager), GCF 6We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules as well as Other therapeutic area, Cardiology and Inflammation – and we need top talent to ensure these molecules become medicines and...

Senior Clinical Research Physician (Senior Clinical Research Medical Manager), GCF 6 We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules as well as Other therapeutic area, Cardiology and Inflammation – and we need top talent to ensure these molecules become medicines...

Description:The Senior HR Specialist is responsible for assisting in the functional processes of the Korea GPGS Hub including office policies, with a specific focus on talent acquisition. The role is a generalist position assisting with a variety of HR functions relating to talent acquisition, colleague relations, payroll, policy administration, compliance...

Position Overview The Senior Actuarial Analyst will perform valuation/financial reporting and analysis of Korea business’ financial result. The role will also contribute to the maintenance and enhancement of the financial forecasting system and analytic foundation by developing/maintaining actuarial models and processes used not only for regular...

Position Overview The Senior Actuarial Analyst will perform valuation/financial reporting and analysis of Korea business' financial result. The role will also contribute to the maintenance and enhancement of the financial forecasting system and analytic foundation by developing/maintaining actuarial models and processes used not only for regular...

ABOUT ABBOTT:Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Structural Heart Business Mission : why we existOur business purpose is to restore health and improve quality of life through the design and provision of...

Senior HR Specialist (Korean National Only) (Contract Role) Global Property & Guest Services Global Property and Guest Services Hub - Seoul KR - 11 - SeoulHuman ResourcesAdministrativeFull-timeReq ID: SEO001902 Summary The Senior HR Specialist is responsible for assisting in the functional processes of the Korea GPGS Hub including office policies,...

Position Overview The Senior Actuarial Analyst will perform valuation/financial reporting and analysis of Korea business’ financial result. The role will also contribute to the maintenance and enhancement of the financial forecasting system and analytic foundation by developing/maintaining actuarial models and processes used not only for regular...