581 Ctd Jobs - Page 7

Dear All, We are looking for a Regulatory Affairs Assistant Manager/Deputy Manager with 7-10 years of experience in pharmaceutical formulations, specifically for the Europe market . Key Responsibilities: Prepare, compile, and submit high-quality regulatory dossiers in compliance with EU and UK market requirements. Collaborate with cross-functional teams (CFTs) to ensure alignment with regulatory standards and timely compliance Maintain accurate and up-to-date regulatory documentation and manage regulatory databases effectively. Demonstrate strong communication skills to engage with internal teams and external regulatory authorities. Possess in-depth knowledge of EU regulatory guidance, proce...

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...

Recorders and Medicare Systems Pvt Ltd is looking for RA 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 latest available ...

What Will You Do: Assess regulatory intelligence for supporting development of local, regional, and global regulatory strategies. Evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle to ensure product compliance and anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions. Assist in the development of regulatory strategy and update strategy based upon regulatory changes. Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities. Provide regulatory information and guidance for product development and pla...

Design, develop, and implement Departure Control Systems for airlines. Collaborate with cross-functional teams to ensure seamless integration of DCS with other systems. Troubleshoot and resolve technical issues related to DCS. Develop and maintain documentation for DCS procedures and protocols. Provide training and support to airline staff on DCS operations. Analyze data to identify areas for improvement in DCS performance. Job Requirements Strong understanding of aviation regulations and standards. Experience with air traffic control systems and communication protocols. Excellent problem-solving and analytical skills. Ability to work effectively in a team environment. Strong communication a...

Roles and Responsibility Publish regulatory submissions according to company guidelines and timelines. Ensure compliance with regulatory requirements and industry standards. Collaborate with cross-functional teams to meet submission goals. Review and edit regulatory documents for accuracy and completeness. Maintain accurate records of submissions and publications. Stay updated with changing regulatory requirements and guidelines. Job Requirements Minimum 2 years of experience in regulatory submissions or a related field. Strong knowledge of regulatory requirements and industry standards. Excellent publishing and communication skills. Ability to work independently and as part of a team. Stron...

Roles and Responsibility Coordinate and manage regulatory submissions, ensuring compliance with relevant laws and regulations. Develop and implement effective submission strategies to achieve business objectives. Collaborate with cross-functional teams to ensure timely and accurate submissions. Conduct thorough reviews of submissions to identify areas for improvement. Maintain accurate records of submissions, approvals, and other relevant documents. Stay up-to-date with changes in regulatory requirements and guidelines. Job Requirements Strong knowledge of regulatory submissions and compliance. Excellent communication and project management skills. Ability to work effectively in a fast-paced...

Roles and Responsibility Coordinate and prepare regulatory submissions for timely and accurate filing. Develop and maintain relationships with regulatory authorities and stakeholders. Conduct thorough reviews of regulatory documents to ensure accuracy and completeness. Collaborate with cross-functional teams to meet regulatory requirements. Stay updated on changing regulatory requirements and implement necessary changes. Ensure compliance with all relevant laws and regulations. Job Requirements Strong knowledge of regulatory requirements and guidelines. Excellent communication and coordination skills. Ability to work independently and as part of a team. Strong analytical and problem-solving ...

Roles and Responsibility Coordinate and manage regulatory submissions, ensuring compliance with relevant laws and regulations. Develop and implement effective submission strategies to achieve business objectives. Collaborate with cross-functional teams to ensure timely and accurate submissions. Conduct thorough reviews of submissions to identify areas for improvement. Maintain accurate records of submissions, approvals, and other related documents. Stay up-to-date with changes in regulatory requirements and guidelines. Job Requirements Strong knowledge of regulatory submissions and compliance. Excellent communication and project management skills. Ability to work effectively in a fast-paced ...

We are looking for a highly skilled and experienced Regulatory Compliance Publisher to join our team at Gratitude India Manpower Consultants Pvt. Ltd., located in the IT Service & Consulting industry. The ideal candidate will have 2-4 years of experience. Roles and Responsibility Develop and implement regulatory compliance programs to ensure adherence to industry standards. Conduct risk assessments and audits to identify areas for improvement. Collaborate with cross-functional teams to ensure seamless execution of regulatory requirements. Publish regulatory documents and reports as required by relevant authorities. Stay updated on changes in regulations and laws affecting the organization. P...

We are looking for a highly skilled and experienced Regulatory Document Publisher to join our team at Gratitude India Manpower Consultants Pvt. Ltd., located in the IT Service & Consulting industry. The ideal candidate will have 3-8 years of experience in regulatory document publishing. Roles and Responsibility Publish and maintain regulatory documents, ensuring accuracy and compliance with relevant laws and regulations. Collaborate with cross-functional teams to ensure timely submission of regulatory documents. Develop and implement processes to improve regulatory document quality and efficiency. Conduct thorough reviews of regulatory documents to identify areas for improvement. Stay update...

We are looking for a highly skilled Regulatory Medical Writer with 3 to 8 years of experience to join our team at Gratitude India Manpower Consultants Pvt. Ltd., located in the IT Service & Consulting industry. Roles and Responsibility Develop high-quality regulatory documents, including clinical trial applications, marketing authorizations, and other related submissions. Collaborate with cross-functional teams to ensure compliance with regulatory requirements and company standards. Conduct thorough research and analysis of regulatory guidelines, laws, and regulations to inform document content. Create clear, concise, and well-structured documents that meet regulatory requirements. Review an...

About The Role 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 referrals o Maximize sales through a network and relationships to ensure strong business o 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 Optim...

Role & responsibilities Responsible for Drug Master Filing submissions to various regulatory agencies like USFDA, European Agencies, Brazil, and other semi-regulatory countries. Review and submission of Response to queries raised on DMF by USFDA, and other agencies. Review and submission of Amendments and revisions of Drug Master Files. Review and ensuring the regulatory compliance of CMC information and manufacturing facilities of advanced intermediated through regular visits, which are intended to submit to regulatory markets. Evaluation of cost reductions processes in regulatory point of view and submitting to different regulatory agencies. Review of OOS, BPR, process validation, and othe...

Roles and Responsibility Provide exceptional customer service and support to passengers. Handle passenger inquiries and resolve issues professionally and courteously. Collaborate with other teams to ensure seamless operations and high-quality service delivery. Develop and maintain thorough knowledge of airline procedures and protocols. Assist passengers with baggage handling and boarding processes. Ensure compliance with company policies and procedures. Job Requirements Minimum 2 years of experience in a related field, preferably in the aviation industry. Strong communication and interpersonal skills are essential. Ability to work well under pressure and handle multiple tasks simultaneously....

Roles and Responsibility Coordinate regulatory submissions with cross-functional teams to ensure timely and accurate delivery. Develop and maintain relationships with regulatory authorities and stakeholders. Prepare and review regulatory documents, including applications, reports, and other submissions. Ensure compliance with regulatory requirements and guidelines. Collaborate with internal teams to resolve issues related to regulatory submissions. Maintain accurate records of regulatory submissions and interactions. Job Requirements Minimum 2 years of experience in regulatory submissions or a related field. Strong knowledge of regulatory requirements and guidelines. Excellent communication ...

Roles and Responsibility Publish and submit regulatory documents to relevant authorities. Ensure compliance with regulatory requirements and guidelines. Coordinate with cross-functional teams to prepare and review regulatory submissions. Maintain accurate records of regulatory submissions and correspondence. Stay updated with changes in regulatory requirements and implement updates accordingly. Collaborate with internal stakeholders to ensure timely submission of regulatory documents. Job Requirements Minimum 3 years of experience in regulatory submissions or a related field. Strong knowledge of regulatory requirements and guidelines. Excellent communication and coordination skills. Ability ...

Roles and Responsibility Manage and publish regulatory submissions, ensuring compliance with relevant laws and regulations. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Develop and maintain relationships with regulatory authorities and other stakeholders. Stay updated on changes in regulatory requirements and implement necessary updates. Ensure accurate and high-quality content in all regulatory submissions. Collaborate with internal teams to resolve issues related to regulatory submissions. Job Requirements Strong knowledge of regulatory requirements and guidelines. Excellent communication and interpersonal skills. Ability to work independently...

Responsibilities 1. To check Artwork for new developed product for Export Market and maintain the record for artworks of packaging materials. 2. To verify all technical documents and information required from QA, QC, Purchase, Marketing, and Production department before compilation of planning of dossier. 3. To prepare and compile registration dossier in CTD, ACTD and Country specific format and submit to concern party. 4. Responsible for query response of dossier.

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...

Description Medical Writer I (CTD/CTT) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovatin...

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...

Purpose The role has overall responsibility for Vaccines portfolio related activities in Regulatory Affairs including interactions with regulatory authorities, government bodies, industry associations and other internal/external stakeholders Main Accountabilities Regulatory ownership with necessary business acumen to support the vaccines business unit (BU) in India, Nepal and Sri Lanka Develop and ensure implementation of strategic regulatory pathways for Sanofi products in terms of market authorizations to enable faster to market Liaison with internal regulatory team such as Global Regulatory to support business continuity related to submissions/approvals for renewals, post approval changes...

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...

Formulation Experience Mandatory: Well aware of EU, Australia, Ukraine & UK market requirement Dossier Preparation in ACTD & CTD Format ICH guidelines Communication skills Documents Management Stakeholder Communication