Academic degree in pharmacy or related scientific field
At least 10 years of experience in Regulatory Affairs in an international environment, preferably in clinical or regulatory strategy
Strong communication skills and ability to work with co-workers and customers in a multinational setting
Excellent teamwork and attention to detail
Requirements:
Lead and contribute to activities across regulatory strategy, lifecycle management, and local regulatory activities
Navigate and manage complex regulatory topics with confidence
Communicate with health authorities (e.g., PMDA) and with clients or partners
Apply knowledge of Japanese regulatory procedures and guidelines for medicinal products and related areas; support customers in Japanese (business fluency) and English (advantage)
Job description
GENERAL INFORMATION
We are looking for a
SENIOR REGULATORY AFFAIRS MANAGER (m/f/x)
Location: remote within Japan
Starting: at the next possible date
YOUR PROFILE
How you’ll hook us:
You have an academic degree in pharmacy or a related scientific field.
With at least 10 years of experience in Regulatory Affairs in an international environment, preferably in clinical of regulatory strategy, you are able to navigate every challenge.
Your strong communication skills allow you to work with co-workers and customers alike.
You are an excellent team worker and thrive in a multi-national environment.
An eye for detail completes your skills.
YOUR TASKS
There are plenty of fish in the sea, but you might be the one we’re looking for if…
…you are well-versed in our wide range of activities from regulatory strategy to life-cycle measures or local regulatory activities.
…your experience allows you to handle complex regulatory topics swimmingly.
…communication with health authorities (i.e. PMDA) and clients or partners isn’t new to you.
…you are knowledgable when it comes to regulatory procedures and guidelines in Japan for medicinal products and beyond.
…you enjoy exploring new product types.
…your business fluency in Japanese enables you to provide our customers with the best possible support. Strong English skills to assist our international customers are an advantagefor this role.
