RA specialist
2주전에
Description
Job Title: RA specialist
Location: South Korea, Seoul
About the role:
Comprehend priorities and objectives of Takeda and commit to working towards it Develop working relationships with GRA, GEMRA and the local regulatory authority to ensure optimal stakeholder management and LOC support Co-operate with local functions to support development and implementation of regulatory plans that support commercial goals and product launch excellence Develop and maintain current information and comprehensive knowledge on designated product portfolio Coordinate and contribute to special project assignments as determined by the Head of Regulatory Affairs / Regulatory Affairs Manager Complete relevant reports within designated timeframes Handle multiple priorities to achieve long and short-term goalsHow you will contribute:
Regulatory submissions
File assigned new drug and variations applications in a timely manner in accordance with agreed regulatory plan Ensure effective product life cycle management and file label updates in accordance with global/local SOPs.What you bring to Takeda:
Regulatory compliance
Ensure continued regulatory compliance through maintenance of registrations by timely submission of post-approval variations and update of regulatory databases Review promotional and non-promotional materials for assigned tasks in accordance with regulatory norms and internal compliance rulesMore about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Locations
Seoul, Korea
Worker Type
Employee
Worker Sub-Type
Fixed Term (Fixed Term)
Time Type
Full time-
RA Specialist
1개월전에
Seoul, 대한민국 Beckman Coulter 풀타임: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...
-
RA IND
4주전에
Seoul, 대한민국 AstraZeneca 풀타임RA 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
4주전에
Seoul, 대한민국 AstraZeneca 풀타임RA 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 &...
-
Seoul, 대한민국 Align Technology 풀타임About 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...
-
Seoul, 대한민국 Align Technology 풀타임About 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...
-
Seoul, 대한민국 Cardinal Health 풀타임The Company and BusinessHeadquartered in Dublin, Ohio, Cardinal Health, Inc. is a global healthcare services and products company, offering tailored solutions for various healthcare facilities worldwide.The company provides proven medical products and pharmaceuticals, enhancing supply chain efficiency from hospitals to homes. Cardinal Health connects...
-
Seoul, 대한민국 Adecco 풀타임Key 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...
-
Seoul, 대한민국 Adecco 풀타임Key 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...
-
Seoul, 대한민국 IQVIA 풀타임Job Overview Manage and lead activities associated with Feasibility and/or Site Identification for regional and/or country projects and/or programs. Essential Functions Manage assigned opportunities/projects/programs for country or region and adhere to timelines and budget. Ensure the site list for assigned studies includes an adequate number of...