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Morunda K.K.

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8 jobs
Morunda K.K.
1 views 4 weeks ago

Head of Regulatory Affairs, Development – Biopharma

APACC-level
Japan

Role Overview Lead Japan Regulatory Affairs activities for development programs, from development through approval and lifecycle management, in collaboration with global and local stakeholders. Key Responsibilities…

Performance Management Stakeholder Management
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Morunda K.K.
1 views 2 months ago

International Regulatory Affairs - Senior Manager/Associate Director

APACSenior
Japan

Department: Regulatory Affairs Reports to: Head of APAC Regulatory Affairs Location: Tokyo Direct Reports: None Summary A global biopharmaceutical company is seeking a highly motivated and energetic professional to…

Strategic Planning
Morunda K.K.
1 views 4 months ago

Associate Director, Device Regulatory Affairs

APAC
Japan

Overview A global biotechnology company is seeking an Associate Director, Device Regulatory Affairs to lead regulatory strategy for innovative medical devices supporting global development and commercialization.…
Morunda K.K.
1 views 4 months ago

Regulatory Affairs Specialist

APAC
Japan

Responsible for regulatory submissions for in vitro diagnostics and medical devices (including instruments, reagents, and software), and for developing market entry strategies in collaboration with related departments.…
Morunda K.K.
1 views last year

[Remote] Regulatory Affairs Expert ~ Medical Device

APAC
Japan

Lead the development and implementation of regulatory strategies for Class III and IV medical devices and IVDs. Specialized in identifying opportunities, delivering effective regulatory solutions, and ensuring timely…
Morunda K.K.
2 views last year

Regulatory Affairs Manager

APAC
Japan

About the Role: A global healthcare consulting firm is seeking their first CMC Regulatory Affairs expert to prepare and review CMC dossiers and advise clients on pharmaceutical development. This role involves leading…
Morunda K.K.
1 views last year

Legal Manager

APACContract
Japan

Collaborate with business functions to provide sound legal and compliance advice that aligns with the company’s strategic goals and supports overall growth. Draft, review, and negotiate a wide range of contracts both…

Contract Lifecycle Management
Morunda K.K.
1 views 2 years ago

Senior Manager Regulatory Affairs

APACSenior
Japan

This role is also responsible for leading the preparation and submission of product Technical Files, Standard Technical Documentation, and other related documents for market authorizations in Japan. The Director will…