Specialist/Coordinator, Regulatory Affairs - Seoul - MSD와 관련된 현재 작업
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Regulatory Affairs Associate
3 개월전에
Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about ensuring regulatory compliance for new products and product amendments? Do you thrive in a fast-paced environment and enjoy working with key stakeholders to navigate regulatory frameworks? If so, we have an exciting opportunity for you to join our team as a Regulatory Affairs Associate at Novo Nordisk Korea. Apply today for a...
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Senior Specialist, Quality
5 개월전에
Seoul, 대한민국 Cardinal Health 풀타임The Company and Business Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a global, integrated healthcare services and products company, providing customized solutions for hospitals, health systems, pharmacies, ambulatory surgery centers, clinical laboratories, and physician offices worldwide. The company provides clinically proven...
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Seoul, 대한민국 Merck KGaA, Darmstadt, Germany 풀타임We are seeking a Regulatory Management Specialist responsible for supporting our export and import regulatory & compliance matters from a pharmaceutical/in-vitro diagnostic perspective.This position will collaborate with Global Regulatory and management stakeholders on various international regulatory compliance projects. The role will support our Life...
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RA Specialist
5 개월전에
Seoul, 대한민국 Ortho Clinical Diagnostics 풀타임The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing...
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Seoul, 대한민국 Merck KGaA, Darmstadt, Germany 풀타임Trade Compliance Coordinator Seeking an experienced Trade Compliance Coordinator to support product review and manage controlled products in export and import regulatory & compliance matters. Key responsibilities include: Supporting product review and managing controlled products in all aspects of export and import regulatory & compliance...
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Seoul, 대한민국 Merck KGaA, Darmstadt, Germany 풀타임Seeking experienced Trade Compliance Coordinator to support product review and manage controlled products for export and import regulatory compliance. Key responsibilities include implementing control procedures, classifying products against regulatory requirements, and providing policy direction and guidance to various business...
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Study Start up
4 개월전에
Seoul, 대한민국 MEDPACE 풀타임Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We...
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P&R Specialist
5 개월전에
Seoul, 대한민국 AstraZeneca 풀타임Role 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...
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P&R specialist
5 개월전에
Seoul, 대한민국 AstraZeneca 풀타임Role 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...
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Regional Medical Advisor
1개월전에
Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about scientific and medical knowledge? Do you thrive in building relationships with key opinion leaders and healthcare professionals? We are looking for a Regional Medical Advisor (1 year contract) to join our team in the Clinical, Medical, Regulatory (CMR) department in Korea. If you are ready to make a difference in the field of...
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Regional Medical Advisor
4 개월전에
Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about scientific and medical knowledge? Do you thrive in building relationships with key opinion leaders and healthcare professionals? We are looking for a Regional Medical Advisor (1 year contract) to join our team in the Clinical, Medical, Regulatory (CMR) department in Korea. If you are ready to make a difference in the field of...
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Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about scientific and medical knowledge? Do you thrive in building relationships with key opinion leaders and healthcare professionals? We are looking for a Regional Medical Advisor (1 year contract) to join our team in the Clinical, Medical, Regulatory (CMR) department in Korea. If you are ready to make a difference in the field of...
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Seoul, 대한민국 AstraZeneca 풀타임Job Responsibilities Medical expert on clinical development and local commercialization decision - Be in charge of newly introducing disease area (across CVRM/R&I/V&I/Rare disease/Oncology) which AZ Korea medical affairs do not yet have coverage of the disease area. - Continuously acquire and update necessary scientific knowledge on new therapeutic...
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Seoul, 대한민국 Kuehne+Nagel 풀타임JOB DESCRIPTION You will be joining our Operational Care Team to add your expertise + skills to the delivery of Operational Excellence. Your Role You will be enabling transport activities by executing bookings, entering orders + generating all required export documentation while liaising with our Customer Care Specialists to ensure all requirements are...
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Real World Evidence Manager
5 개월전에
Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about driving strategic initiatives and programs in the field of Real World Evidence (RWE)? Do you have experience in managing teams and engaging with stakeholders? If so, we have an exciting opportunity for you to join our Clinical, Medical, Regulatory Affairs (CMR) department as a Real World Evidence Manager. Read on to learn more and...
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Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about driving strategic initiatives and programs in the field of Real World Evidence (RWE)? Do you have experience in managing teams and engaging with stakeholders? If so, we have an exciting opportunity for you to join our Clinical, Medical, Regulatory Affairs (CMR) department as a Real World Evidence Manager. Read on to learn more and...
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Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about driving strategic initiatives and programs in the field of Real World Evidence (RWE)? If so, we have an exciting opportunity for you to join our Clinical, Medical, Regulatory Affairs (CMR) department as a Real World Evidence Associate. Read on to learn more and apply today for a life-changing career. About the departmentThe...
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Seoul, 대한민국 Novo Nordisk 풀타임Are you passionate about driving strategic initiatives and programs in the field of Real World Evidence (RWE)? If so, we have an exciting opportunity for you to join our Clinical, Medical, Regulatory Affairs (CMR) department as a Real World Evidence Associate. Read on to learn more and apply today for a life-changing career. About the departmentThe...
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Seoul, 대한민국 Novo Nordisk 풀타임Would you enjoy helping to move the pharmaceutical industry forward by facilitating the communication of scientific data and the sharing of knowledge among medical experts all over the world? Does interacting with leading Global Medical Doctors and Scientists on new innovative portfolio interest you? If yes, join us on an exciting journey as a Medical...
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Seoul, 대한민국 Pfizer 풀타임PURPOSE Primary Care Medical Manager (MM) is the in-house expert for the therapeutic areas to which they are assigned in Primary Care area. MM acts as local medical representative and core member of the Therapeutic Area (TA) and Brand team, where they provide medical input and expertise for overall TA/Brand strategy. MM plays a key role in the...
Specialist/Coordinator, Regulatory Affairs
2 개월전에
Supports Regulatory Associate Director and team with the regulatory impact assessment, overall planning, validation of change scope and regulatory intelligence.
Partners very closely with Country Regulatory Affairs and the Outsourcing Partner (for some processes) during the planning and execution of the business process or a project to collect necessary inputs for the accurate planning, validates country specific requirements.
Participates in the country or sub-regional (project) meetings to ensure alignment between country and regional or global stakeholders.
Acts as the global Artwork point of contact between the CRA’s and the Artwork Center to coordinate the AW implementation process (including regulatory management of the bundled changes and the shared packs)
Forecasting of Artwork volume and planning
Monitors the regulatory execution milestones (e.g HA submissions and approvals), facilitates the necessary follow-ups and escalations cross functionally and cross divisionally, as applicable.
Prepares the metrics for the designated business process.
Reports monthly and quarterly project updates by using the designated communication dashboards.
Prepares high quality labeling, artwork packages, and conducts assessments of captioning and artwork management. These activities are aimed at supporting the timely submission of new Marketing Authorization Applications, variations, and supplementary marketing authorizations. These tasks are associated with labeling and artworks activities. Partnering with local CRAs to be able to submit to local authorities, maintains local files, updates tracking systems, databases, and handles minor translations.
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description:
- Will be eligible to work for MSD in your country of residence
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:09/30/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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