Senior Manager/Associate Director, International Regulatory Affairs

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. This position is based in the Tokyo office.

State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.

Qualified Pharmacist is a plus.

Fluent in Japanese and English.

State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.

Proven track record for preparing, submitting, and gaining approvals for JNDAs.

The candidate is expected to have a thorough understanding of relevant drug development regulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities.

Experience as clinical scientist and/or in-depth understanding of clinical development as a regulatory strategist is highly desired.

Proficiency with computer and standard software programs is required. The candidate is expected to be fluent in English, both verbal and written (technical). Strong collaborative skills are needed as this position requires close working relationships with stakeholders both inside and outside of the company. Good verbal, written and presentation skills are also required.

List the key positions, internal and external, with which the job incumbent must interact.

BioMarin is Headquartered in California.

The position will report directly to the Head of APAC Regulatory Affairs based in Tokyo.