Head of Regulatory Affairs
Hiring Company

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About the Role
Greater Tokyo, Japan Area (Hybrid)
The Company is seeking a Head of Regulatory Affairs to take on a pivotal role in leading the regulatory environment in Japan. The successful candidate will be responsible for a wide range of initiatives, including the development of regulatory strategy, approval applications, and team development. This leadership position involves overseeing compliance with domestic regulations, driving approvals, and managing risk. The role also requires governance management for license maintenance and safety management systems, as well as aligning regulatory strategy through collaboration with cross-functional and global teams. Building and maintaining relationships with regulatory authorities and external stakeholders is a key aspect of the job. Applicants must have a pharmacist license, a minimum of 10 years' regulatory-related work experience in the pharmaceutical, medical device, or cosmetics industry, and a proven track record in end-to-end new product registration. Experience in dealing with regulatory authorities, particularly in the Japanese market, is essential. The ideal candidate will have leadership experience, be adept at managing a small team, and have a background in a multinational matrix organization. Preferred qualifications include English language skills, experience in the beauty or dermatology field, and a strong background in healthcare, especially consumer health products. The role demands advanced communication, negotiation, and problem-solving skills, as well as the ability to work autonomously and as part of a team.
Functions:
- Operations
About the Company
Globally renowned healthcare company
Industry
Hospital & Health Care
Type
Privately Held
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