Head of Regulatory Affairs

The Company is seeking a Head of Regulatory Affairs to play a pivotal role in the establishment of a new organization within the pharmaceutical field. The successful candidate will have a senior position, leading the regulatory affairs department and will be responsible for driving operations with a high degree of autonomy. This includes overseeing all aspects of drug approval processes, ensuring compliance with pharmaceutical-related laws and regulations, and staying abreast of the latest industry information. The role also involves the preparation and submission of regulatory documents, negotiation and coordination with regulatory authorities, and collaboration with internal departments. The Head of Regulatory Affairs will be a key figure in the planning of regulatory strategies for new products, project progress management, and will be expected to have a proactive and autonomous approach to problem-solving. Applicants must have a minimum of 5 years' experience in regulatory affairs within the pharmaceutical industry, with a focus on post-marketing regulatory maintenance and liaison with regulatory authorities. A Bachelor's degree in a science or engineering field is required, along with fluency in Japanese and conversational English. Preferred qualifications include experience as a Chief Marketing Officer in a pharmaceutical company, management experience in regulatory affairs, and the ability to drive work with a high degree of autonomy. The position offers a fully remote and fully flexible work environment, allowing the successful candidate to work from anywhere in Japan.