Senior Manager, Regulatory Manager

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Job details

Company overview

We are a foreign pharmaceutical company. Through a merger with an international biopharmaceutical company, we have introduced innovative biotechnology to the Japanese market. Through highly specialized medical information activities, we are enhancing our presence in the Japanese market. Focusing on cancer, cancer immunotherapy, and infertility treatment, we provide innovative healthcare solutions to the people of Japan.

Responsibilities

• Effective manage regulatory pathway for Life Science (LS) products and services in Japan, cover the areas of biopharma processing, pharm & food materials (APIs, pharmaceutical excipients, food additives), medical devices, IVDs, equipment/instrument, biologics and animal derived materials, etc.
• Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations in terms of Life Science interests. Safeguard company strategic interests and objectives in arising guidance, standards and regulation.
• Monitor and report on changes of relevant regulatory and compliance environment with impact with the Life Science business. Analyze available regulatory and compliance information.
• Effective coordination of strategic activities with the company subject matter experts, local regulatory bodies and industry associations. Secure flow of information from/to authorities, industry associations and the Life Science organization.
• Training and support to internal stakeholders, external customers and relevant regulatory bodies. Provide relevant training to educate local marketing/sales colleagues about new regulatory trends and developments that drive our value proposition. Definition of processes to implement upcoming regulatory needs and requirements.
• Closely work with global/regional regulatory surveillance & advocacy team and regulatory subject matter experts to link the local advocacy activities with global/regional advocacy activities.
• Drive, manage and coordinate registration / notification / listing activities in Japan. Ensure the correctness and timeliness of these activities, interim follow-up change management and final outcome. Ensure tracking, maintenance and reporting of registration / notification / listing status.
• Provide regulatory guidance in risk assessment, identify regulatory impact to the Life Science and provide regulatory recommendations to mitigate potential risk. Take active role to represent company in delicate or risk potential matters with regulatory agencies, inspectors and trade associations.
• Provide regulatory support to marketing, sales and customers via consultation, seminars and training events.

Requirements

• Degree in life sciences or related area. Pharmacist will be a plus.
• Fluent in Japanese native & English (verbal and written) is required.
• Experience of minimum 8 years in life science or pharmaceutical or biotech industry, extensive knowledge in pharmaceutical and life science products. Related Regulatory experience must to have.
• Broad and extensive regulatory knowledge of Japan laws and regulations of PMDA/MHLW, customs and chemicals authorities. Proven knowledge of Japan regulations in medical devices/IVDs and equipment. Familiar with US and European regulations and industrial regulatory guidelines in above mentioned areas. (nice to have)
• Experience working in a global, matrix environment.
• People management experience to lead a team in complex and fasting changing environment.
• Excellent interpersonal, presentation, listening and communication skills.
• Strong organizational and time management skills.
• Ability to manage multiple priorities and deliver accurate outcomes.
• Ability to indirectly influence other organizations and cultures.
• Ability to train and educate others.
• Effective management by influence.
• Good listening skills with the ability to analyze and respond to given situations quickly and effectively.
• Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels.
• Experience in thought leadership.
• Ability to work in multi-cultural teams.
• Proficient in MS Office Software (Word, Excel, PowerPoint, Project).
• Able to travel.

Salary

12 - 17 million yen

Location

Tokyo