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RA Associate Manager
Posté 10 mars 2023
Ho Chi Minh City, Ho Chi Minh - Vietnam
Demander un identifiant 262088
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Location working: Hanoi city
- Independently perform regulatory activities in order to support successful local approvals of New marketing authorization and maintaining Marketing Authorizations including renewal, variations, site registration, originator and tenders related submission during the lifecycle of both Chemical and Biologics.
- Provide strategic input into projects to meet business objectives
- Master in regulations for Drug and Medical device.
- For projects assigned, develop and provide input to the development of sound regulatory strategies and properly execute them. Elaborates risk mitigation plans that support the company’s portfolio. Critically review regulatory submissions for portfolio.
- Act as functional expert on local/regional/global project teams for projects, interpreting issues and provide strategic input to project team on the application of local regulations, review processes and submission requirements.
- Perform and maintains all regulatory activities for assigned projects and products under responsibility.
- Tracking and push the submissions at HA with impacts; follow up the dossier status with Experts as deem necessary to be able to reach the targeted approval timeline.
- Develop and manages optimal labeling for all products throughout the product lifecycle in close alignment with global labeling group
- Review internally and submit HA of promotional material
- Monitor regulatory environment/local regulatory partners/stakeholders, assess impact on assigned portfolio and timely communicate to internal stakeholders. Works on mitigation plan to optimize submission strategies and maximize business benefit.
- Keeps close contact to the affiliates/ for exchange of regulatory requests and information regarding the allocated tasks
- Ensure compliance with local regulations and corporate policies and procedures.
- Documentation management: archiving, maintains and provides RA documents to relevant stakeholders
- Ensures timely and accurate data entry/maintenance into databases, online systems.
- Work closely with SNO Dept. for supply management.
- Work closely with QA department on product complaints, quality alerts
- Work with GDS on PSUR and PV activities
Who you are:
- Bachelor of Pharmacy University.
- Fluent English communication (good written and spoken English).
- Attention to details in documentation.
- At least 5 years experience working in Regulatory Affairs in Pharmaceuticals & Medical Device Industry; Imported product & MNC organization is preferred.
- Solid experience in dossier compilation & regulatory compliances follows current regulations & laws
- Be effectively in building trust & effective relationship with Health Authorities and Experts either from the North or the South, especially with HN Medical University, HN Pharmacy University, NICVB.
- To be able to follow up the dossier at HA independtly to get approval with high impact. Strong achievements of Site registration, Innovator declaration and Clinical validations as is preferred.
- Familiar with working on regulatory management systems
- High sense of details and well-organized & Teamwork
- High accountability with result oriented
- Effective communication skill
- Agile & be able to lead works independently
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!