378 Ctd Jobs - Page 15

Review and analyse information from the general ledger and other accounting records to ensure accuracy and completeness, taking corrective action as necessary. Manage compliance with R2R accounting standards across the group. Identify gaps in finance processes that may have been overlooked, mitigating potential material reporting issues. Challenge and hold senior finance managers and staff accountable in instances where inappropriate accounting is detected. Lead and support the team, providing guidance to help members achieve established goals and KPIs. Consistently adhere to all deadlines. Prepare and review balance sheet analyses and reconciliations, review profit and loss statements, and ...

Minimum of 2-5 years of experience in the pharmaceutical industry and should be able to independently compile ACTD, CTD Dossiers and Country-specific Dossiers for international markets, Adept at query resolution etc. Required Candidate profile Qualifications: A BPharm/ M Pharm with knowledge and experience of international regulatory affairs in Pharmaceutical Industry.

We are looking for a highly skilled and experienced professional to join our team as an Entrepreneur In Residence in the Management Consulting industry. The ideal candidate will have 14 years of experience. Roles and Responsibility Develop and implement business strategies to drive growth and expansion. Collaborate with cross-functional teams to identify new business opportunities and improve existing processes. Conduct market research and analyze industry trends to inform business decisions. Build and maintain relationships with key stakeholders, including clients and partners. Identify and mitigate risks to ensure compliance with regulatory requirements. Monitor and report on key performan...

• Preparation of CTD/eCTD format drug master file and its submission to various regulatory authorities including USA, Europe, Canada, Australia, China, Japan, Korea, Brazil and ROW market • Preparation of query response of drug substance for various and less regulated markets and customers. • Preparation of applicant part and closed part for various authorities for different customers. • Preparation of annual updates and amendment of drug master files US via ESG, ASMF via CESP, KDMF via MFDS Korea, • Preparation and submission of CEP applications and responses to EDQM via CESP. • Preparation of CEP LOAs & LOA’s and declarations of various customers and authority. • To collect and evaluate sc...

Responsibilities of a Regulatory Affairs - Manager for HOD / Senior RA Executives : Manages all the functions of the Regulatory Affairs Department including but not limited to * Scheduling activities of the department. 1. Dossier Preparation and Review Oversee the preparation of technical product dossiers, ensuring accuracy, completeness, and compliance with regulatory requirements. Review dossiers prepared by team members to ensure they meet national and international standards. Provide guidance and technical expertise to the team during dossier preparation. 2. Regulatory Submissions and Approvals Manage applications for licenses, permissions, and other regulatory approvals in the country o...

Preparation of DMFs for different markets in CTD and eCTD formats. Coordination with cross-functional dept to manage the documents. Supporting marketing team & QC/QA/R&D in various capacity. Preparation of Declarations and other supporting docs. Required Candidate profile Candidate from Pharma - API industry and should have 8+ Years of Experience in Regulatory Affairs. Perks and benefits Canteen Transportation Health Insurance

We are looking for a highly motivated and detail-oriented Audit Assistant to join our team at Cretum Advisory. The ideal candidate will have 2-4 years of experience in the financial services industry, preferably with a background in accounting or finance. Roles and Responsibility Assist in conducting audits and reviews of financial statements and reports. Develop and implement audit procedures to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to identify areas for improvement and provide recommendations. Analyze data and prepare reports to support audit findings and recommendations. Maintain accurate and up-to-date records of audit activities and resu...

RESPONSIBILITIES Author high- quality CMC documentation for US FDA submissions for Post approval supplements/Annual reports in accordance with latest guidance assuring technical congruency and regulatory compliance. Tracking labeling updates and handle corresponding CBE-0 filing. Provide support in PADER submissions. Review and Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues proactively Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends Co-ordination with stakeholders on a regular basis to extend all technical support required from regulator...

To drive sales and ensure business targets are achieved o Aggressively drive the sales numbers and achieve the business targets for Retail loan products and through cross selling while continuing to enhance and upgrade the client relationships.o Retain and expand the company's base of customers for retail loan product so as to ensure repeat business or referralso Maximize sales through a network and relationships to ensure strong businesso Develop and maintain strong liaisons with the clients for repeat business or referrals.o Ensure the files are processed from login stage to disbursement and liaise with internal departments (Operations and Credit) for completion.o Optimize team productivit...

Position: Regulatory Affairs Executive Location: Andheri (E) Role & responsibilities Ensure that the company's products comply with the regulations of the regions where they are distributed. Keep up to date with national and international legislation, guidelines and customer practices. Prepare dossiers, documents and samples as per requirement of markets for participation in tenders. Collect, collate and evaluate scientific data from a range of sources and prepare dossiers as per the market demand in CTD /ACTD formats. Monitor and set timelines for registrations variations and renewal approvals and submissions. Write clear, accessible product labels and patient information leaflets. Advise c...

We are looking for a skilled Program Leader to join our team in the BPO/Call Centre industry. The ideal candidate will have 4 to 8 years of experience and be based in R1 RCM Global Private Limited. Roles and Responsibility Lead compliance programs to ensure adherence to regulatory requirements. Develop and implement effective compliance strategies to mitigate risks. Collaborate with cross-functional teams to identify and resolve compliance issues. Conduct audits and reviews to ensure compliance with industry standards. Provide training and guidance on compliance policies and procedures. Monitor and report on compliance metrics to senior management. Job Requirements Strong knowledge of compli...

The ideal candidate must possess strong communication skills, with an ability to listen and comprehend information and share it with all the key stakeholders, highlighting opportunities for improvement and concerns, if any. He/she must be able to work collaboratively with teams to execute tasks within defined timeframes while maintaining high-quality standards and superior service levels. The ability to take proactive actions and willingness to take up responsibility beyond the assigned work area is a plus. Specialism KYC, AML, Due Diligence Senior Analyst Roles & responsibilities: Responsible for managing KYC operations for a large Investment Bank Independently handle multiple clients POCs ...

Job TitleSA LocationMumbai / Pune Skill- End to end KYC, Periodic Review, AML, and Due Diligence Shift Timings:APAC , EMEA , NAM Roles & Responsibilities This role will include the understanding and implementation of the KYC lifecycle. He/she would be responsible for opening, amending, reviewing and exiting clients according to established policies and procedures, and also review clients transactions to detect and report either proposed or completed unusual transactions. Key responsibilities include: Performing the due diligence on new Clients, requesting the KYC information, documentation, review and verification of received documentation and making an analytical risk assessment for new Cli...

Job TitleSA LocationMumbai / Pune Skill- End to end KYC, Periodic Review, AML, and Due Diligence Shift Timings:APAC , EMEA , NAM Roles & Responsibilities This role will include the understanding and implementation of the KYC lifecycle. He/she would be responsible for opening, amending, reviewing and exiting clients according to established policies and procedures, and also review clients transactions to detect and report either proposed or completed unusual transactions. Key responsibilities include: Performing the due diligence on new Clients, requesting the KYC information, documentation, review and verification of received documentation and making an analytical risk assessment for new Cli...

Role & responsibilities We are seeking an experienced and detail-oriented Executive Officer Drug Regulatory Affairs with a strong background in injectable dosage forms to join our regulatory team. The ideal candidate will be responsible for regulatory submissions, dossier compilation, and lifecycle management of products specifically targeting the Rest of the World (ROW) markets, with a focus on Asia (e.g., ASEAN, Middle East, South Asia). Key Responsibilities: Prepare, compile, review, and submit high-quality regulatory dossiers (CTD/eCTD formats) for injectable formulations for registration in ROW/Asian countries. Ensure that all submissions comply with country-specific regulatory guidelin...

Author high- quality CMC documentation for US FDA submissions (Original ANDA/Deficiency responses/Post approval supplements/Annual reports) in accordance with latest guidance's assuring technical congruency and regulatory compliance. US submissions Required Candidate profile Hands on experience on using eCTD software and attending e-publishing requirements throughout project lifecycle. knowledge of CTD /eCTD for submission of dossiers B. Pharm / M. Pharm 5 - 8 Years

We are looking for a highly skilled and experienced Analyst to join our team in the IT Services & Consulting industry. The ideal candidate will have 6-9 years of experience in KYC analysis. Roles and Responsibility Conduct thorough analysis of customer data to identify potential risks and ensure compliance with regulatory requirements. Develop and implement effective risk management strategies to mitigate identified risks. Collaborate with cross-functional teams to resolve complex issues and improve overall process efficiency. Provide expert guidance on KYC procedures and best practices to junior team members. Stay up-to-date with industry trends and regulatory changes to ensure the organiza...

Role & responsibilities Reviewing of documents received from Project Managers and then preparing and filling of dossiers for BE NOC/CT NOC/GCT/biosimilar Clinical trial as per New Drugs and Clinical trials rules 2019. Reviewing, preparing and filling of dossiers seeking Import License for Investigational Products for bio-studies/Clinical Trials for DCG(I) submission as per New Drugs and Clinical trials rules 2019. Export of biological samples of biostudies/Clinical Trials done in India for DCGI approval. Reviewing, preparing and filling of dossiers seeking approval from ICMR, New Delhi for import of biological samples for analysis purpose Reviewing, preparing and filling of dossiers for gett...

Role Overview A senior leadership position responsible for implementing strategic initiatives and driving operational excellence across multiple US regulatory & compliance & client services teams. This role drives operational excellence, business growth, and talent development across related units while ensuring delivery of high-quality services in a complex, high-volume environment. The position focuses on departmental strategy, resource optimization, and cross-functional leadership. Support and assist IQEQ’s investment adviser client by providing regulatory compliance services through oversight of the execution and continuous improvement of the client’s compliance program, which meet the r...

The ideal candidate must possess strong communication skills, with an ability to listen and comprehend information and share it with all the key stakeholders, highlighting opportunities for improvement and concerns, if any. He/she must be able to work collaboratively with teams to execute tasks within defined timeframes while maintaining high-quality standards and superior service levels. The ability to take proactive actions and willingness to take up responsibility beyond the assigned work area is a plus. Specialism KYC, AML, Due Diligence Senior Analyst Roles & responsibilities: Responsible for managing KYC operations for a large Investment Bank Independently handle multiple clients POCs ...

Role / Nature of Job : Assembly / Machine Operator Follow and support Safety and Environmental practices on the shop floor, including hazard identification and safe working methods, in line with ISO45001 & ISO14001 standards. Operate machines and follow established processes after required training, ensuring adherence to ISO9001:2015 standards. Support shift production targets by executing assigned operations and coordinating with relevant support teams. Maintain discipline in resource usage to support cell-level productivity and cost control (Volume-adjusted VOH). Carry out production activities as per the shift plan to meet internal customer requirements. Build skills through On-the-Job Tr...

Skill- End to end KYC, Periodic Review, AML, and Due Diligence Shift Timings:APAC , EMEA , NAM Roles & Responsibilities This role will include the understanding and implementation of the KYC lifecycle. He/she would be responsible for opening, amending, reviewing and exiting clients according to established policies and procedures, and also review clients transactions to detect and report either proposed or completed unusual transactions. Key responsibilities include: Performing the due diligence on new Clients, requesting the KYC information, documentation, review and verification of received documentation and making an analytical risk assessment for new Clients Thoroughly and succinctly doc...

The ideal candidate must possess strong communication skills, with an ability to listen and comprehend information and share it with all the key stakeholders, highlighting opportunities for improvement and concerns, if any. He/she must be able to work collaboratively with teams to execute tasks within defined timeframes while maintaining high-quality standards and superior service levels. The ability to take proactive actions and willingness to take up responsibility beyond the assigned work area is a plus. Specialism KYC, AML, Due Diligence Senior Analyst Roles & responsibilities: Responsible for managing KYC operations for a large Investment Bank Independently handle multiple clients POCs ...

The ideal candidate must possess strong communication skills, with an ability to listen and comprehend information and share it with all the key stakeholders, highlighting opportunities for improvement and concerns, if any. He/she must be able to work collaboratively with teams to execute tasks within defined timeframes while maintaining high-quality standards and superior service levels. The ability to take proactive actions and willingness to take up responsibility beyond the assigned work area is a plus. Senior Analyst Roles & responsibilities: Responsible for managing KYC operations for a large Investment Bank Independently handle multiple clients POCs establish self as a valued partner ...

Preparation, compilation, and review of dossiers for USFDA and ROW markets ANDAs, amendments, and deficiency responses for the USFDA. Strategize, plan, and oversee USFDA submissions – ANDA, PAS, Annual Reports, and post-approval changes.