· Job facts
In your role as RA Expert, You will report to RA Chapter Lead/ Director and your main responsibilities are:
· Carry our all regulatory affairs responsibilities and activities for assigned products at local affiliate with high compliance standard.
· Collaborate with both internal cross-functional team members, as well as with external stakeholders to achieve objectives.
· Understand Roche Pharma Vietnam & IDT vision & shared goals and translate it into clear prioritized objectives for regulatory.
· Plan and implement registration strategies to assure business continuity and support business
· Gather, analyze and communicate internal and external regulatory intelligence
· Develop innovative, risk-based registration plans and submissions strategies for responsible products with guidance from RA Chapter Lead
· Embed themselves in Integrated Disease (IDT) Teams and represent regulatory function on providing regulatory expertise and input in cross-functional meetings to co-create ways to achieve rapid and continued access to medicines
· Initiate regulatory fillings aligned with business and supply needs to assure business continuity.
· Monitor and communicate all regulatory fillings status and respond to internal and external questions.
You have University Degree majoring in Medicine/Pharmacy. Further qualification, experience, skills and competencies are:
· At least 3 years of experiences in the RA role in a MNC pharmaceutical companies.
· Fluency in written and spoken English and Vietnamese
· Proficient in basic computer software/ applications
· Highly organized, with ability to prioritize own tasks as well as those of others. Good planning skills
· Builds trustful and effective relationships with stakeholders
· Good practical experience of contacts with Health Authorities and local partners
· Commitment to performance measures of time, cost and quality
· Takes responsibility, drives results and achieves expected outcomes.
· Who we are
At Roche, 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer.