Senior Manager/Associate Director, International Regulatory Affairs

JOB DESCRIPTION

Job Title:

Senior Manager, International Regulatory Affairs

Department / CostCenter:

Regulatory – 210

Reports to (Job Title):

Head of APAC Regulatory Affairs

Job Code:

Location:

Tokyo

Date Prepared:

February 2025

Full-Time Part-Time

Regular Temporary

Exempt Non-Exempt

SUMMARY DESCRIPTION

State the overall function or purpose of the job.

We are seeking a highly motivated, energetic professional capable of working effectively in fast-paced environment to join our International Regulatory Affairs team. This position will be responsible for developing the strategy, preparation and execution of regulatory submissions (marketing applications (MAs) and post-marketing maintenance) for BioMarin products, interfacing with the Japanese regulatory authorities (e.g.MHLW, PMDA), and for providing insight and support for clinical development in Japan...