Senior Regulatory Specialist

Regulatory Oversight ProfessionalThe Regulatory Specialist is responsible for managing and coordinating regulatory examinations, overseeing regulatory issues, and producing reporting and metrics for senior management. This role requires strong understanding of regulatory, compliance, or audit processes, as well as proficiency in Excel, PowerPoint, Visio,...

Regulatory Compliance Specialist Job DescriptionAs a Regulatory Compliance Specialist, you will play a critical role in ensuring our products meet all relevant regulatory requirements.Develop and implement effective compliance strategies to mitigate risks and ensure successful project execution.Build and maintain strong relationships with regulatory...

Job Title: Regulatory Affairs Specialist">Job Description:">We are seeking a detail-oriented professional to support end-to-end submissions for global markets.">Key Responsibilities:">">Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.">Contribute to Lifecycle Management (LCM) activities...

Job Title: Regulatory Compliance SpecialistThis is a pivotal role that requires a strong understanding of regulatory requirements and compliance procedures.About the Role:Key Responsibilities:Regulatory Approvals & Licensing: Obtain and renew mandatory licenses and approvals, including PCPNDT Act approvals, ART Registration, Bombay Nursing Home Registration,...

Regulatory Compliance SpecialistThe key objective of this role is to maintain regulatory compliance and ensure adherence to international guidelines and country-specific requirements.Key Responsibilities:Screen, analyze, and prioritize regulatory documents for timely submission;Draft, compile, and review product dossiers in compliance with customer and...

Job Opportunity: Regulatory Affairs SpecialistWe are seeking a detail-oriented and highly organized professional to support end-to-end submissions for global markets.Key Responsibilities:Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.Contribute to Lifecycle Management activities by...

Job Overview: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:Compile and publish regulatory documents according to global health authority requirements.Ensure compliance with...

Regulatory Reporting SpecialistThis role is ideal for individuals who possess a deep understanding of regulatory reporting requirements and compliance.Maintain comprehensive process documentation, data integrity, and handle internal audit queries.Collaborate with stakeholders on strategic initiatives and process improvements.Perform user acceptance testing...

Job Description:We are seeking an experienced Senior Assistant Director to lead and manage activities in the Food Regulatory Affairs department. The successful candidate will be responsible for driving policy initiatives, liaising with government departments, engaging with industry stakeholders, generating revenue, and organizing impactful initiatives.Key...

Key Job Responsibilities:Manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault Publishing.Compile, format and publish regulatory documents according to global health authority requirements.Evaluate compliance with regulatory guidelines (FDA, EMA) and internal processes.Perform quality control of eCTD submissions, including...