Regulatory Submission Publisher

Key Responsibilities:- Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing.- Compile, format, and publish regulatory documents according to global health authority requirements.- Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.- Perform QC of eCTD submissions,...

Key Responsibilities:Prepare and manageBLA (Biologics License Application)submissions in eCTD format usingVeeva Vault eCTD Publishing .Compile, format, and publish regulatory documents according to global health authority requirements.Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.Perform QC of eCTD submissions, including file...

JOB PURPOSE:To actively manage a portfolio of journals, developing its quality, profile, market share and financial performance in line with Sage's strategy. To maintain positive relationships with journal editorial boards and publishing partners, delivering high quality service and guidance.KEY ACCOUNTABILITIES• Actively manage journal editor performance,...

About the client: PSShas been mandated to hire aRegulatory Affairs Managerfor one of the leading pharmaceutical companies in India.Job PurposeTo register Formulation products in the European markets, handling all submissions and taking care of all queries.Key ResponsibilitiesThe candidate should have sound knowledge of all Regulatory Filings, be well-versed...

Hi Everyone,I am on lookout for Regulatory Affairs Associate for US based, diversified pharmaceutical company in Navi Mumbai.Please refer below JD and share your profile on pallavi.ag@peoplefy.comExperienced in preparing, review and compile regulatory submissions. Maintain compliance with US FDA and ICH requirements. Should have experienced in pre-submission...

Job Description About the client: PSS has been mandated to hire a Regulatory Affairs Manager for one of the leading pharmaceutical companies in India. Job Purpose To register Formulation products in the European markets, handling all submissions and taking care of all queries. Key Responsibilities - The candidate should have sound knowledge of all Regulatory...

BIOTRONIK is one of the leading manufacturers of cardio - and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success...

Role Objective Key objective of this role is to prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements. The role involves coordination with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance with...

Role ObjectiveKey objective of this role is to prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements. The role involves coordination with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance with...

Should be well conversant with IRAC, Exposure, Large exposure norms, Resolution Plan Implementation, Sensitive sector monitoring, etc. Exposure in preparation of DSB, CRILC, PSL, MSME, SLBC, Defaulter, NPA, Bureau reporting (CIBIL), NeSL submission, Quarterly disclosure preparation, Risk Based Supervision submission, Potential NPA tracking, Exception...