Associate Consultant, Regulatory Affairs
IQVIA
Responsibilities:
Assist the Head of Regulatory services in assuming primary or secondary regulatory responsibility for assigned projects by providing the project team with regulatory information, guidance, training, support and strategic planning based on applicable regulations issued by the regulatory agencies across JAPAC.
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. (Strategic guidance, dossiers preparation, submission activities & etc.)
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 webinar to internal and external stakeholders.
Assist in identifying business opportunities for regulatory projects.
Requirements:
3 - 5 yrs 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.
IQVIA is 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. Learn more at https://jobs.iqvia.com