Regulatory Affairs Specialist

Regulatory Operations SpecialistThe primary objective of this role is to provide expert regulatory guidance and oversight to ensure compliance with relevant regulations, laws, and standards.Responsibilities include:Conducting comprehensive audits and reviews of banking products to ensure adherence to regulatory requirements.Maintaining accurate and...

Global Regulatory Intelligence SpecialistAs a key member of our team, you will play a critical role in monitoring and analyzing the global regulatory landscape within the life sciences industry.Job DescriptionWe are seeking an expert in regulatory affairs with experience in the pharmaceutical or medical device industries to join our team as a Global...

Regulatory Affairs SpecialistJob Description:We are seeking an experienced Regulatory Affairs Specialist to lead and manage CMC regulatory activities for USFDA submissions.This role will be responsible for preparing, reviewing, and filing ANDA documents.The successful candidate will oversee the compilation and submission of Annual Reports, amendments, and...

We are seeking a seasoned professional to lead quality assurance and regulatory affairs efforts in the Medical Device Industry.Key responsibilities include ensuring compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.The ideal candidate will have relevant experience in quality systems and regulatory frameworks for medical devices.Ensure...

Job Opportunity:We are seeking a highly skilled Regulatory Compliance Specialist to join our team.The role involves preparing, reviewing, and submitting regulatory documents to global health authorities, ensuring adherence to applicable regulations.Key Responsibilities:Regulatory Filing: Prepare, review, and submit regulatory filings, including IND, NDA,...

Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to support our end-to-end submissions for global markets.Key Responsibilities:Regulatory Document Preparation: Prepare regulatory documents and/or evaluate post-approval changes in compliance with global regulatory requirements.Lifecycle Management: Contribute to...

Role SummaryWe are seeking a Compliance Officer to ensure adherence to regulatory guidelines, support governance processes, manage audits and inspections, and provide compliance guidance to senior leadership and board-level committees.Key Responsibilities:Regulatory Monitoring & Implementation:Continuously track and evaluate regulatory updates relevant to...

Job OverviewThis position offers a unique opportunity to lead and manage medical review teams, ensuring compliance with regulatory requirements. As a Senior Medical Advisor, you will be responsible for reviewing study protocols, drafting medical monitoring plans, and interpreting clinical data.Key ResponsibilitiesLead as a medical monitor/Medical expert in...

Job Summary">We are seeking a highly skilled Regulatory Publishing Specialist to join our team. In this role, you will be responsible for preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing.">Key Responsibilities:">">Submission Preparation: Compile, format, and publish regulatory documents according to global health...

Compliance Manager - Food RegulationsOur organization seeks an experienced Compliance Manager to oversee food regulations across various markets.Key Responsibilities:Develop and maintain in-depth knowledge of domestic and export food labelling regulations across multiple markets (EU, US, UK, GCC, Canada, APAC, SE Asia, Latin America).Monitor, analyse and...