Support pharmaceutical and medical device customers for registration of new products and the license maintenance of existing products (including pre-fillable syringes).
Obtain the documentation and information necessary for registration in the targeted countries
Collaborate with Global RA Team Members to ensure timely execution of regulatory submissions with business objectives and customer deliverables.
Answer and fulfill requests and queries originating from regulatory authorities (MFDS, FDA, EU Notified body, Japan PMDA, China NMPA, Malaysia NPRA, etc.)
Identify applicable regulations and standards, carry out regulatory monitoring, assess the regulatory impact of changes, inform the appropriate internal and external stakeholders.
Qualifications
Pursue regulatory knowledge and expertise in countries regulatory topics
Minimum of 4-5 years regulatory or equivalent experience within a device or pharmaceutical company
Proactive, high performance, result oriented and manage projects with ethical integrity
Manage multiple projects and deadlines
Good verbal and writing English skill are preferred
Proficient in MS Office, including Word, Excel and PowerPoint
