378 Ctd Jobs - Page 4

Role & responsibilities Dossier Preparation and Submission: Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. Regulatory Compliance and Updates: Stay informed of changes in Asian or Regulated market regulations, ensuring timely implementation of updates to maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. Documentation and Record Keeping: Maintain wel...

Role & responsibilities Prepare clinical study report of BABE studies and patient based clinical trial studies (PK end point/PD end point/clinical end point studies) on the basis of data received from clinic after completion of study as per regulatory requirement/SOPs/client standards/client approved templates. Final compilation of the project report with respected appendices as per e-CTD including Module 2 (Summary report) and Module 5(Compilation of study report, literature, appendices & BR report) and/or applicable regulatory guidelines & requirements. Submit final compilation signed report with e-CTD to client. Co-ordinate with Project Manager for report requirement, sponsor's comments &...

We are seeking a Regulatory Affairs Executive with 1 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Responsibilities include preparing, compiling, and maintaining regulatory documentation in accordance with regional requirements, coordinating with cross-functional teams to gather necessary data, and ensuring timely submission of dossiers. The candidate should be well-versed with regulatory guidelines, and capable of handling multiple projects simultaneously.

Role & responsibilities Responsible for overseeing all aspects of regulatory compliance within a company, ensuring that new drug product drug substance applications and marketed products adhere to all relevant regulations set by regulatory agencies like the MHRA, EMA, TGA ,DIGIMED and other international bodies, by leading a team to manage registration processes, maintain compliance, and strategically navigate complex regulatory landscapes to successfully launch and maintain pharmaceutical products on the market. Developing and implementing comprehensive regulatory strategies for new drug development, including clinical trial design, data submission plans, and market access strategies. Leadi...

About this role: Wells Fargo is seeking a Senior Quality Assurance Administrator. In this role, you will: Provide support and scoring guidance quality assurance staff by answering questions on regulations or compliance, procedures, policies and First Call Resolution Escalate key maintenance errors identified during scoring process and ensure resolution of same, reviewing programs, processes, documentation, to ensure compliance with internal company requirements or government regulations Review systems to ensure company standards are met, exceptions are notated, and issues escalated as necessary Assist in development and design of product specific databases Review and score work Prepare calib...

We are hiring a highly experienced Senior Regulatory Affairs Executive for our pharma company in Ahmedabad. The role involves dossier preparation & submission (CTD/ACTD/eCTD), product registration, regulatory strategy, compliance with WHO-GMP/ICH/global guidelines, and handling ROW, LATAM, SEA, Africa, Pacific market approvals. The candidate will also coordinate BE studies, manage lifecycle activities, review technical files, liaise with authorities, maintain regulatory records, and mentor junior team members.

Job Description: Regulatory Affairs Executive (ROW Markets) Industry: Pharmaceuticals Experience: 3-5 Years Loaction: Chennai Key Responsibilities: Dossier Submissions: Compile & submit ACTD, CTD, and country-specific dossiers for ROW markets. Regulatory Queries: Prepare and respond to health authority queries on submitted dossiers. Document Review: Review BMR, specifications, COA, MOA, and technical documents for compliance. Artwork Coordination: Ensure accuracy in labeling & packaging artwork with regulatory standards. FDA Compliance: Maintain records for FDA licenses (Product Permission, CoPP, FSC) . Legal Documentation: Track notarized & legalized documents for international submissions....

• Develop and review content for various regulatory documents; ensure quality as per setegulatory standards and compliance requirement. • Good understanding of global regulatory dossier formats and ACTD/CTD/NeeS/paper dossier format. • Candidate will need to author and/or review clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD for submission to the Health Authorities in EU and APAC markets, respectively. Key requirement: • Good medical/pharma/scientific knowledge that can be applied in developing content for regulatory documents • Experienced in the development and review of clinical and non-clinical documents under Module 2, 4 and 5 of eC...

: Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at ...

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Document Management Systems (DMS) Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will engage in the design, construction, and configuration of applications tailored to fulfill specific business processes and application requirements. Your typical day will involve collaborating with team members to understand project needs, developing innovative solutions, and ensuring that applications are optimize...

Role Overview As the General Counsel / Head of Crypto Compliance , you will: Oversee regulatory compliance for token sales, fundraising, and Web3 projects . Liaise with global regulators (SEC, MAS, ESMA, DIFC, FCA, etc.) to ensure licensing and structuring. Ensure adherence to AML/KYC, investor protections, and jurisdiction-specific legal frameworks . Mitigate legal risks associated with crypto exchanges, DeFi protocols, and NFT marketplaces . Develop internal legal policies to align with global securities, tax, and financial regulations . Key Responsibilities 1. Legal Regulatory Compliance for Web3 Token Launches Ensure full compliance for ICOs, IDOs, STOs, and private token sales . Provide...

We help our customers free up time and space to become an Autonomous Digital Enterprise that conquers the opportunities ahead - and are relentless in the pursuit of innovation! The candidate will be an integral part of the AskHR team, a high-touch and customer-focused function within BMC HR. The candidate is expected to deliver an exemplary employee experience with every interaction. Candidates needs to be approachable, customer focused, flexible, action-oriented, and innovative along with great verbal and written communication skills. They should have great attention to detail while supporting a broad range of HR activities including data management, benefits administration, offboarding and...

We help our customers free up time and space to become an Autonomous Digital Enterprise that conquers the opportunities ahead - and are relentless in the pursuit of innovation! Responsible for invoice processing in Oracle R12, Invoice are in multi-language and multi-currency. Supplier Reconciliation, analyzing invoices to identify duplicate invoices in day to day processing. Here is how, through this exciting role, you will contribute to BMC's and your own success: Invoice processing for different countries Ensuring that all the internal controls are met while processing the invoices Duplicate review before entering data into financials Preparing Weekly/Monthly reports as needed for AP Ensur...

Your role and responsibilities Play key role in Project Controlling, financial analysis, closing activities including audits, reporting of the division and support project management team in all financial and commercial matters and actively drive the projects performance. The work model for the role is: #Li - Onsite This role is contributing to Motion Traction Division in Bangalore/Vadodara. You will be mainly accountable for: Supports the tender manager and Project Manager on financial aspects. Provides input to negotiations on commercial issues. Provides input in local risk review process. Provides input to the Project Execution Plan on financial aspects. Prepares project invoices, financi...

Compilation and submission of eCTD dossier for new product application & post approval submission Query response, PAS,CBE and annual report, drug listing Review of artwork and submission of labelling section Maintain product life cycle.

General Summary: The Technical Support Specialist II is responsible for assisting our partners in diagnosing and resolving a partners product issues or questions. This role works in partnership with cross-functional teams to troubleshoot, resolve, and document issues, getting partners back on track to having a positive experience with our products. Essential Duties & Responsibilities: Provides support to cross-functional teams, with a high attention to detail Researches, analyzes, and documents findings May influence others within the Technical Support team through the explanation of facts, policies, and practices Interacts with partners to provide technical support via email, phone, chat, c...

We help our customers free up time and space to become an Autonomous Digital Enterprise that conquers the opportunities ahead - and are relentless in the pursuit of innovation! Responsible for invoice processing in Oracle R12, Invoice are in multi-language and multi-currency. Supplier Reconciliation, analyzing invoices to identify duplicate invoices in day to day processing. Here is how, through this exciting role, you will contribute to BMC's and your own success: Invoice processing for different countries Ensuring that all the internal controls are met while processing the invoices Duplicate review before entering data into financials Preparing Weekly/Monthly reports as needed for AP Ensur...

Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Coordination with various departments to collect the necessary information required for preparation of the CTD / ACTD / Country specific dossier. Assist in preparation of dossier as per country specific requirement. Any other job assigned by immediate supervisor/HOD Pr...

About The Role Job TitleAssociate Process Manager - SkillKYC Mumbai and Pune|Full-time (FT)|Financial Markets Shift Timings-APAC/EMEA/ NAM |Management Level- SA | Travel Requirements- NA Role & Responsibilities 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 assign...

Eisai Pharmaceuticals India Pvt. Ltd. is looking for Coating & Inspection Executive to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the ...

Job Responsibilities: Dossier preparation/review as per country specific guideline/CTD guideline Timely query response submission to Distributor/ MOH Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement) Preparation, review & release of artworks & sales order as per country approval Variation documents preparation and filing as per country requirements Timely dispatch of tender documents to country/parties as per deadline Candidate profile Should be able to review & interpret the requirement as per country specific/ tender guideline/Query received from MOH Should be able to review various plant documents for dossier preparat...

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications

Role & responsibilities " Responsible for local regulatory activities (driven by local or corporate initiatives) and operations with respect to new product registration, new indications and life cycle management. The individual will execute all the regulatory activities related to assigned portfolio for India and neighboring countries (Sri Lanka, Bangladesh & Nepal) as per Business needs. To act in compliance with country policies and practices to reduce companys exposure to Regulatory risks. Regular Follow up with officials in Health Authorities and to keep updated on changes to local regulatory environment/trends and impact of the regulatory requirements changes to the local business oppor...

Regulatory Affairs Job Opportunity! Desired Experience : 3- 9 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Job Responsibilities: Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World Health Organization. Experienced in handling, management and expansion of product portfolios, markets/ territories. Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC. Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, E...