JOB DESCRIPTION Job Title: Associate Director, Regulatory Affairs Japan Department / Cost Center: Regulatory – 210 Reports to (Job Title): Head of APAC Regulatory Affairs Job Code: Location: Tokyo Date Prepared: April 2024 Full-Time Part-Time Regular Temporary Exempt Non-Exempt
Work Schedule Other Environmental Conditions Office Job Description When you’re part of the team, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe.
■ 職務内容 / Job Description Medical Communication Scientist (MCS) is a role name in AZKK and is generally known as medical writer. MCS is responsible for the authoring of clinical-regulatory documents and submission packages that communicate the evidence
Title: Regulatory Affairs Manager Company: IPSEN K.K. Job Description: Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health
Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive
This is what you will do: Associate Director, Regulatory Affairs is responsible for overall pharmaceutical affairs associated with obtaining pharmaceutical product approval. The duties include complying with Japan pharmaceutical affairs act, developing good relations with the regulatory authority,
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring
Lead regulatory submission process, to contribute expansion of business. Maintain of product registration and related lincenses like MAH or manufacturing site through change control process. Requires basic knowledge of IVD/MD regulation and QMS. Will also cover regulations about
Job Description The Senior Manager / Manager of Clinical Pharmacology in Clinical Pharmacology & Pharmacometrics (CPP) serves as the clinical pharmacology country lead on program, clinical pharmacology, and clinical study teams, providing strategic leadership and expertise
Description Who We Are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, were the house of iconic brands - including Dr.Ci:Labo®, NEUTROGENA®, AVEENO®,
Job Description Summary -Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
This is what you will do: The Senior Manager, Project Management is accountable for the generation and maintenance of program timeline for Japan local portion including Advisory Board meeting, internal governance endorsements, PMDA consultation, J-CTN, clinical
Job Description Summary Demand Planner will be the core of maintaining stable supply of Sandoz products to our Japanese customers and patients as well as maintain company’s healthy financial performance. This role drives Demand and Supply
Description Kenvue is currently recruiting for: Legal Entity Controller Job Description: The Legal Entity Controller role primarily oversees the legal entity (LE) financial close process , financial reporting process, ensuring the integrity and precision of the
Be part of a critical member in the RA organization. Lead in RA development/strategy activities to obtain product approval for various unmet medical needs. Client Details * Global leading pharmaceutical business specialising in womens health *
Take lead in medical writing activities in authoring clinical/regulatory documents as well as submission requirements to obtain product approval. Align with global business strategies for local requirements Client Details * One of the top global biopharmaceutical companies in
Career Category Clinical Job Description Responsible for Ensuring that all statistical aspects of documentation pertaining to clinical programs and non-study activities meet required standards and are statistically correct. Influencing study design and analysis, and defending statistical
