Regulatory Affairs Expert
15 hours ago
We are seeking a highly skilled Regulatory Affairs Expert to join our team in JAPAC. The successful candidate will be responsible for delivering regulatory projects in a timely and proactive manner, managing projects by coordinating with in-country regulatory team leads, identifying and interpreting regulations, guidelines, and other pertinent information issued by applicable regulatory agencies.
Key Responsibilities:- Assist the Head of Regulatory services in assuming primary or secondary regulatory responsibility for assigned projects.
- Deliver on regulatory projects in a timely and proactive manner, manage projects by coordinating with in-country regulatory team leads.
- Identify and interpret regulations, guidelines, and other pertinent information issued by the applicable regulatory agencies and other regulatory organizations.
- Review scientific data, publications, and related papers as appropriate for various regulatory projects to ensure compliance with regulations.
- Develop effective product registration strategies by performing critical review and gap analysis of product documentation.
- Establish relationships with regulatory agencies, health bodies, internal and external stakeholders.
- Ensure revenue is recognized by managing professional activities and internal stakeholders' finances allocation.
- Deliver training workshops and regulatory webinars to internal and external stakeholders.
- 3-5 years of regulatory affairs experience.
- Demonstrate comprehensive regulatory affairs expertise, aptitude for activities related to regulatory affairs and quality compliance for products market access and maintenance.
- Familiarity with regulatory documents, general contents, and the methods of filing and tracking.
- Good interpersonal and negotiating skills, with an ability to identify and resolve issues efficiently and effectively.
- Ability to read/synthesize technical materials and prepare clear/concise written documents.
- Ability to juggle competing priorities to meet deadlines while maintaining high-quality work.
As a Regulatory Affairs Expert at IQVIA, you will have the opportunity to work with a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.
Salary: $80,000 - $110,000 per annum (dependent on location and experience).
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