Regulatory Affairs Specialist

Position OverviewThe Regulatory Affairs Regulatory Affairs Supervisor plays a pivotal role in supporting the electronic publishing of regulatory submissions for national and regional regulatory agencies, as well as FUJIFILM Diosynth partner companies. This position focuses on moderate to complex regulatory submissions in both eCTD and non-eCTD format.This...

About UsFUJIFILM Diosynth Biotechnologies is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.Job...

About the RoleWe are seeking a highly experienced Regulatory Affairs Director for Biologics to join our team. The ideal candidate will have a deep understanding of biologics, including vaccines, gene therapy, and mAb, as well as experience working in a CDMO environment. This role will involve developing, implementing, and maintaining individual sub-systems...

About This OpportunityWe are seeking an experienced Quality Assurance-Compliance Specialist II-Audit and Inspection to join our team at FUJIFILM Diosynth Biotechnologies. As a key member of our quality assurance team, you will play a vital role in ensuring compliance with our quality policies and site SOPs, supporting the development and implementation of...

About Us:Rabobank New Zealand is a leading bank dedicated to supporting the needs of our customers and communities. We are committed to upholding the highest standards of ethics and integrity in all aspects of our business.Role Description:The Regional Head of Compliance will be responsible for leading our compliance function across Australia and New...

Job ResponsibilitiesObtain data/documents from multiple internal teams for exchange and/or communication with FUJIFILM Diosynth partner companies.Upload information to the Regulatory documentation management location for future use.Compile and report key information to pertinent stakeholders within the Quality team to ensure proper visibility and...

Job OverviewThe Regulatory Compliance Specialist III will be responsible for ensuring compliance with regulatory requirements in the pharmaceutical industry. This role involves reviewing and approving technical documentation, conducting quality audits, and identifying areas for improvement.The ideal candidate will have a strong understanding of cGMP...

Key Responsibilities:">The Regulatory Compliance Specialist for Biologics will be responsible for ensuring that all biologic products manufactured at our facility meet the required regulatory standards.Main Responsibilities:">Develop, implement, and maintain QA oversight activities to meet all cGMP regulatory requirements for phase-appropriate clinical and...

About the RoleWe are seeking a highly skilled and experienced Regulatory Affairs Manager to join our team at FUJIFILM Diosynth Biotechnologies. As a Regulatory Affairs Manager, you will be responsible for supporting the electronic publishing of regulatory submissions for national and regional regulatory agencies, and FUJIFILM Diosynth partner companies.Key...

Job Summary:OverviewFujifilm Diosynth Biotechnologies is seeking a highly skilled Quality Assurance - Compliance Specialist II - Audit and Inspection to support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.Key ResponsibilitiesWork collaboratively with site...

About FUJIFILM Diosynth BiotechnologiesWe are a leading biotechnology company dedicated to the development of innovative pharmaceuticals. Our team of experts is committed to ensuring the quality and safety of our products, and we are seeking a highly skilled Manufacturing Compliance Coordinator II to join our ranks.Job SummaryThe Manufacturing Compliance...

**Job Overview**We are seeking an experienced investigator to play a crucial part in ensuring the city's water services comply with all relevant regulations and legislation. This is a 12-month fixed-term opportunity covering for parental leave.The successful candidate will be responsible for conducting proactive and responsive inspections of non-compliance...

**Responsibilities*** Conducting inspections to identify non-compliance and breaches of consent conditions, bylaws, management plans, and other relevant legislative requirements.* Working closely with internal stakeholders to ensure compliance obligations are understood.* Issuing enforcement notices and taking appropriate action to ensure compliance.*...

Key ResponsibilitiesThe successful candidate will be responsible for:Ensuring water services comply with regulatory requirements.Inspecting sites to identify potential non-compliance issues.Collaborating with stakeholders to resolve compliance matters.Developing and implementing compliance strategies.What You'll Enjoy About This RoleYou'll have the...

About UsFUJIFILM Holdings America Corporation is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status,...

Fujifilm Diosynth Biotechnologies is seeking a Quality Assurance - Compliance Specialist II - Audit and Inspection to support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance. This position requires excellent written and oral communication skills, as well as...

Position OverviewSummary:The Quality Assurance Regulatory Affairs Supervisor is responsible for supporting the electronic publishing of regulatory submissions for national and regional regulatory agencies, and FUJIFILM Diosynth partner companies. The primary focus of this position is on moderate to complex regulatory submissions in both eCTD and non-eCTD...

Role OverviewThe Quality Assurance-Compliance Specialist III-Audit and Inspection is responsible for supporting all associated responsibilities in compliance with quality policies and site SOPs. This position requires a strong understanding of GMP regulations and the ability to apply this knowledge to support business growth and maintenance of inspection...

**Job Overview:**At Graymont Limited, we are seeking an experienced Health, Safety and Environment (HSE) Specialist to join our team. The successful candidate will be responsible for supporting operational sites, functions, disciplines, and project managers in achieving compliance with Company and regulatory requirements.**Key Responsibilities:**Support a...

Company OverviewThe pharmaceutical industry has never been more crucial, and FUJIFILM Diosynth Biotechnologies is at the forefront. As a pioneering biotechnology company, we are dedicated to pushing the boundaries of innovation and advancing life-changing treatments. Our team consists of passionate individuals who share a common goal: to make a real...