378 Ctd Jobs - Page 6

1. Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other markets. 2. Support product development, registration, & lifecycle management in Europe 3. Manage Regulatory Compliance & Approvals Required Candidate profile 1. Minimum 10 years of experience in Formulations OSD 2. Willing to work in Chennai 3.Strong expertise in European, EMA, MHRA & other international regulatory framework 4.Knowledge of ICH & regulatory

Roles and Responsibilities Should Have Formulation Experience. Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. Responding to queries with in the time lines receive...

About the Role: Grade Level (for internal use): 10 About the Role: EMEA Benefits Specialist The Team: The Global Benefits Team is a team of specialists that focuses on the Wellbeing and Benefits for our colleagues across the globe supporting 40+ countries. The Impact We invest in our success as a company by investing in our people. At S&P Global, we are committed to comprehensive, competitive benefits for our people. We provide benefits to support the health and financial needs of our people while helping make their working life experience more rewarding. This is a critical role that touches each of our colleagues and is critical to our People First Philosophy. This role supports the wellbei...

We are seeking a highly experienced and detail-oriented Regulatory Affairs Specialist with 5 to 15 years of experience in the pharmaceutical industry, specifically handling regulatory requirements for ROW (Rest of the World) / PICs (Pharmaceutical Inspection Co-operation Scheme) markets. The ideal candidate will have strong expertise in dossier preparation, international registration processes, and a solid understanding of global regulatory frameworks including ICH CTD, ACTD, and EU CTD formats .

Elite Overseas Education Consultant is looking for Europe Counselor to join our dynamic team and embark on a rewarding career journeyDeveloping and implement an all-encompassing counseling plan.Conduct group or individual counseling sessions.Excellent communication skills and high emotional intelligence abilitiesExcellent problem-solving and critical thinking skills

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 assigned work area is a...

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...

NKP Pharma is looking for EXECUTIVE / ASSISTANT MANAGER (SALES) to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new...

Dear All, We are looking for a Regulatory Affairs Executive with 2-4 years of experience in pharmaceutical formulations, specifically for the ROW (Rest of World) market . Hands-on experience in the preparation and submission of regulatory dossiers in CTD and ACTD formats for Rest of the World (ROW) markets. Proficient in drafting and submitting responses to regulatory queries within stipulated timelines. Experienced in managing post-approval activities, including renewals and variations. Skilled in handling Drug Master File (DMF) notifications. Adept at reviewing and ensuring the accuracy and compliance of quality documents such as product specifications, stability data, Product Development ...

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP for Oil & Gas Joint Venture Accounting Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage...

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Document Management Systems (DMS) Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure project milestones are met, facilitating discussions to address challenges, and guiding your team through the development process. You will also ...

We are looking for a highly skilled and experienced Field Risk Officer to join our team at Equitas Small Finance Bank. The ideal candidate will have 2-3 years of experience in the BFSI industry, preferably with a background in risk management or a related field. Roles and Responsibility Conduct thorough analysis of customer data to identify potential risks and develop strategies to mitigate them. Collaborate with cross-functional teams to implement effective risk management plans and monitor their progress. Develop and maintain relationships with key stakeholders, including customers, vendors, and internal teams. Identify and assess new business opportunities and provide recommendations for ...

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Get feedback from all the countries for respective variation, and their timely submission. 7. renewals. 8. Master data Updating. 9. Follow ups with plant for documentation regularly and review meeting. Preferred candidate profile eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products Must hav...

1. Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other markets. 2. Support product development, registration, & lifecycle management in Europe 3. Manage Regulatory Compliance & Approvals Required Candidate profile 1. Minimum 10 years of experience in Formulations OSD 2. Willing to work in Chennai 3.Strong expertise in European, EMA, MHRA & other international regulatory framework 4.Knowledge of ICH & regulatory

Role & responsibilities Develop and implement regulatory strategies to support research projects and product development initiatives. Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to integrate regulatory considerations into pro...

Original Application submission Labeling development for original applications (NDA/ANDA) in accordance with RLD labeling, current FDA guidance (s) and carve outs based on patents and exclusivity claims Labeling Query responses/ REMS and Patent Amendments/ PNP Requests Thorough review/interpretation of FDA comments. Review of revised labeling and response. Tracking/ Review for Completeness/ Timely Submission of REMS correspondence/ Amendments Review of patent amendment & proprietary name review request Submission of Final Approval Requested Life Cycle Management Track RLD labeling changes Initiate labeling revision activity as per RLD label revision/safety labeling change SLC notification fr...

Rama Super Speciality Hospital is looking for ENT Surgeon to join our dynamic team and embark on a rewarding career journeyExamining patients to diagnose and evaluate their medical conditions, including the use of diagnostic equipment and tests such as X-rays and MRI scans.Developing and implementing treatment plans, including the use of surgical procedures and other medical therapies.Performing surgical procedures to treat conditions such as ear infections, hearing loss, sinusitis, voice and speech disorders, sleep apnea, and head and neck tumors.Communicating with patients and their families, discussing diagnoses and treatments, and answering questions and concerns.Collaborating with other...

Role & responsibilities * Data Entry and Updation in Regulatory Information Management System. * Dossier preparation (New/ Renewal/ Variations) for different countries. * Other RA Related Activities. Perks and benefits * 5 days working Environment * Additional Benefits.

To ensure that products with all regulations and legislation, both National and international,throughout the product lifecycleThe RAP works closely with R&D manufacturing QA/QC and mkt to ensure timely registration,compliance and approval of products

Do you want to contribute to the future of healthcareAs Siemens Healthineers values those who dedicate their energy and passion to this cause, our company’s name is dedicated to our employees. It’s their pioneering spirit, blended with our long history of engineering in the ever-evolving healthcare industry that truly makes us unique as an employer. We offer you a flexible and dynamic environment and the space to stretch beyond your comfort zone to grow both personally and professionally. Sound interesting Then come in and join India team as Regulatory Affairs Specialist. Your tasks and responsibilities: Planning and preparing product related medical device submissions for the products manuf...

: Job TitleOperations Expert, AS Location:Bangalore, India Role Description Overview: Deutsche Bank is committed to being the best financial services provider in the world, balancing passion with precision to deliver superior solutions for our clients. This is made possible by our peopleagile minds, able to see beyond the obvious and act effectively in an ever-changing global business landscape. As youll discover, our culture supports diverse perspectives, driven by a shared sense of purpose. Margin Operations responsible for minimizing Deutsche Banks counterparty credit risk on its collateralized derivatives portfolio. We aggregate the Banks exposure across trading activity globally, admini...

RESPONSIBILITIES Compilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU and/or UK. Experience with AUS-NZ submissions would be an added advantage. Publishing in eCTD format and submission to respective Regulatory Agencies. Compilation and submission of variation applications for EU and/or UK. Review of documents related to compilation of dossiers, variations and query responses. Up to date knowledge of EU regulatory guidelines and requirements. DESIRED SKILLS Must have hands on experience on using eCTD software and e-publishing requirements throughout project lifecycle Should have handled initial MAA submission & Variations for EU. Good technical knowledge w...

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Sea...

Responsible for overseeing al 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. Leading the preparation and su...

: Job Title CSO Environmental and Social Due Diligence & Sustainable Finance Manager LocationMumbai, India Corporate TitleAS Role Description The Chief Sustainability Office is responsible for developing Deutsche Banks sustainability strategy and driving its implementation across all business divisions, infrastructure functions, and regions. Its core responsibilities include defining the strategic framework, coordinating the Banks sustainable finance activities, setting ESG standards, and overseeing regulatory and disclosure obligations. It comprises four teams: Strategy & Regional Governance , Execution, Data & Regulatory , Group Sustainability , and ESG Transparency . Strategy & Regional G...