Ensure effective presentation of data, complete and timely responses (including CTAs).
MANPOWER TEMPORARY SERVICES REGISTRATION
Assesses scientific data provided by specialist units for registration purposes against JAPAC national and regional regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps.
Provides leadership and support to RA personnel in the affiliates. Primary interface with local health authorities via RA personnel in the affiliates. 
Primary interface to and from the RA personnel in the affiliates. Provide regulatory guidance and support of medical device/combination products to team member and across TAs. Represent RA in any cross-functional initiatives being led out of the JAPAC commercial offices. Monitoring and influencing changes in regulatory policy and intelligence for the country or countries of responsibility. Define and implement the Area & Affiliate regulatory strategies and deliverables for a portfolio of compounds (early development, late development, marketed) for the JAPAC Area. 
To act as the representative of the regulatory affairs organization to the JAPAC commercial organization for all aspects related to the assigned therapeutic area and products of responsibility. They are currently looking for Senior Regulatory Affairs Specialist They strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, health and gastroenterology, in addition to products and services across its Aesthetics portfolio. 
Our client, a MNC company with the mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
0 kommentar(er)
