Offers “Roche”

Expires soon Roche

Regulatory Affairs Expert

  • Hà Nội, Việt Nam
  • Personal services

Job description

·  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.

Make every future a success.
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