378 Ctd Jobs - Page 10

Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Markets, LATAM, ROW International @ Pharma Formulation -PUNE City. Person will be responsible for DRA function for Pharma Formulation for Advanced Markets / EU The candidate should be conversant with preparing dossiers for Finished Formulations for EU Preferred candidate profile Honest, Hard Working. Growth Mindset (Important). Good Communications Skills. Relevant Experience in Pharma Only Candidate with Relevant Experience may apply. We also encourage rightful candidates to write directly to us to "info@vekocare.com" with a proper covering note.

Designation : Executive / Sr Executive Department : Regulatory Affairs (API Industry only ) Qualification :M.Sc in Chemistry. Experience: 3 to 6 years. CTC : Rs 5 lacs to 7 lacs. Key Skills: DMF, NDA / ANDA dossiers, Regulatory Affairs. Filing of new Drug Master Files (DMFs) / Dossiers to respective countries (US, Europe, EDQM, Japan ) by compiling the documents as per CTD requirements. To interact and coordinate with R&T and manufacturing sites for all regulatory submissions (New filing and Amendments) and customer requirements. Maintaining life cycle of products as per the respective region wise requirements. Submission of Applicant Part to customers as per the requirement. Candidates work...

Job Description Responsible for overall engineering functions of OSD - plant Responsible for O&M of utility,HVAC, Water System and Process maintenance. Responsible for PM I Calibration I Facility maintenance and department safety functions. Responsible for regulatory I statutory audit compliance. Responsible for Preparation of maintenance reports budget and expenses control. Work Experience 20-25 years Education Graduation in Engineering or Electrical B.Tech in Engineering or Mechanical Engineering Competencies

Role & responsibilities : As a Responsible Position , the Person, should be working as business owner / manager for the Export of Veterinary Pharma across world markets . Handle Existing clients , ensure business growth . Our business model is B2B 1.Business Development- Identify new product opportunities and develop promotional strategies. Participate in international exhibitions (CPhI, etc.) 2.Client Management : Present products to clients with technical detailing. Address formulation-related questions during negotiation. 3 Technical Evaluation: Understand product composition, dosage forms, and stability. Evaluate cost-effectiveness of formulations Suggest alternative formulations as per ...

We are looking for a highly skilled and experienced Technical Manager to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee technical aspects of mortgage operations. Develop and implement process improvements to enhance efficiency and productivity. Collaborate with cross-functional teams to achieve business objectives. Analyze and resolve complex technical issues related to mortgage processing. Ensure compliance with regulatory requirements and industry standards. Provide technical guidance and support to junior team members. Job Requirements Strong understanding of technical management principles and practices. Experience working with mortgage products ...

We are looking for a highly skilled and experienced Technical Manager to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee technical aspects of mortgage operations. Develop and implement process improvements to enhance efficiency and productivity. Collaborate with cross-functional teams to achieve business objectives. Analyze and resolve complex technical issues related to mortgage processing. Ensure compliance with regulatory requirements and industry standards. Provide technical guidance and support to junior team members. Job Requirements Strong understanding of technical management principles and practices. Experience working with mortgage products ...

ICICI Prudential Life Insurance co Ltd is looking for SALES MANAGER - PSF EAST 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 ful...

* Collaborate with cross-functional teams on regulatory strategy . Stay current with evolving regulations related to Sulphur import/export in different countries, including customs regulations, trade agreements, and safety standards Annual bonus Provident fund Accidental insurance

Providing insights on industry and market developments, including policy and regulatory updates to advocate for favourable outcomes, Analysis of Regulations, Guidelines, Policies, Important order, etc to derive meaningful insights & actionable for higher management, Support in Policy Advocacy, legal & regulatory on filing petitions with appropriate authority, Support in review of bidding, bid documents, RFS & PPA, Support in creation of Memorandums of Understanding (MOU) with government bodies, ensuring alignment with legal and strategic frameworks, Supporting business development and project expansion, ensuring alignment with ENGIEs strategy and objectives, Building positive relationships w...

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 - Preparing Dossiers for registration of products in various ROW markets - Knowledge of CTD format is mandatory Preferred profile Qualification: B. Pharm and M. Pharm Experience: 2 years Salary: 20,000 to 40,000 per month Health insurance Accidental insurance Annual bonus

ICICI Prudential Life Insurance co Ltd is looking for SALES MANAGER - PSF EAST 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 ful...

Role & responsibilities Write and/or edit high-quality safety and clinical documents, medical sections of Periodic Benefit-Risk Evaluation Reports, medical sections of Addendum to clinical overviews, Clinical Study Reports (CSR), Disease and product ID Cards, and clinical evaluation reports, product alerts and trial transparency documents with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines. Works independently on documents with minimal supervision, and act as buddy or mentor to the medical writers, and efficiently peer reviews. Essential Job duties and responsibilities: 1) Participate ind...

IndustryPayment Aggregator / Financial Services / Payments business Functional AreaFinancial Services, Payments RoleManager Reporting toSenior Manager, Legal Key Skills: Drafting, Vetting, and Negotiating Agreements, providing Legal Advice, Risk Identification and Management ExperienceMinimum 6 years’ experience; ideally with some experience in the Financial Services/ FinTech/ Payments industry. EducationUniversity Degree in law. A Masters Degree in Law is not mandatory, but will be an added advantage. LocationBangalore PRIMARY RESPONSIBILITIES: Business Drafting, negotiating, and closing contracts with the internal and external clients. Providing legal advice in framing/ review of policies,...

: Established in 1991, Matrix (www.matrixcomsec.com) is a leader in Security and Telecom solutions for modern businesses and enterprises. Matrix has launched cutting-edge products like Video Surveillance Systems - Video Management Software, Network Video Recorder, and IP Camera, Access Control and Time-Attendance Systems as well as Telecom Solutions such as Unified Communications, IP-PBX, Universal Gateways, VoIP and GSM Gateways, and Communication Endpoints. These solutions are feature-rich, reliable, and conform to international standards. Having global footprints in Asia, Europe, North America, South America, and Africa through an extensive network of more than 2,500 channel partners, Mat...

About the Role: Grade Level (for internal use): 09 The Role This position is an individual contributor within the Internal Audit team responsible for performing audit engagements including U.S. Sarbanes-Oxley (SOX) Compliance testing. This position will contribute significantly to SOX testing efforts and evaluating compliance with corporate policies, assessing risks over the IT operating environment and identifying operational efficiencies. The Impact The IT SOX Specialist will work closely with your direct manager and the process owners to gain an understanding of key processes, key controls, identify control gaps by strengthening and monitoring the internal control environment to provide a...

Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About Team The Statutory Audit Team is responsible for ensuring the accuracy and compliance of our company's financial statements with relevant laws and regulations. This team conducts thorough audits to identify areas of improvement, mitigate risks, and provide assurance on the financial health of the organization. With expertise in financial reporting, ...

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 &...

Key Responsibilities: Lead and manage regulatory activities and documentation (individually and through a team). Ensure compliance with South Africa/country-specific guidelines. Review and peer-review regulatory submissions (electronic & non-electronic). Track and oversee project timelines and regulatory deliverables. Liaise with internal/external stakeholders to ensure timely documentation. Prepare/review APQR summary reports and implementation notifications. Stay updated on changing regulatory legislation. Guide and train internal teams on regulatory requirements. Ideal Candidate Profile: 6-9 years of experience in Regulatory Affairs. Strong knowledge of South African and/or international ...

Analysts engage in risk, compliance, and financial crimes projects to serve Promontory clients within the banking and finance industry – helping them meet and exceed regulatory expectations. Analysts are expected to positively contribute to Promontory’s success in a variety of areas, including BSA, anti-money laundering surveillance and reporting assistance, OFAC sanctions compliance, and other areas relevant to today’s heightened regulatory climate. Analysts must possess excellent writing, research, analytical, and critical thinking skills, and other applicable experience that leads to success in the role, such as strong work ethic and natural curiosity. Analysts must be able to judiciously...

Key Responsibilities 1. Dossier Preparation and Submission CTD/eCTD Compilation: Assemble and submit regulatory dossiers in Common Technical Document (CTD) format, including modules for clinical, non-clinical, and quality data.

Regulatory Strategy & Planning Submissions & Approvals Team Leadership & Governance Global Compliance & Maintenance Cross-Functional Collaboration External Stakeholder Management

Role & responsibilities 1. To list the Mc/Utilities/Motors/Compressors/Heavy Mcs data / Name plate details inside the factory premises and preserve it. 2. To identify the CTQ / CTD machinery in the plant data from PPC & Production & QC 3. Maintain the Critical Spares 24x7. 4. Mc Daily check sheet data to be captured which will be recorded by Production 5. Prepare the Preventive Maintenance schedule and assign the team to do and record it 6. Maintain the History Card. 7. Do the scheduling for Predictive Maintenance with identified Spare materials. 8. Capture MTTR / MTBF data and do the action to improve it. 9. Capture the Revex Expenditure on the point of Maintenance - Major critical spares e...

Role & responsibilities Regulatory Strategies & Submissions: Develop & implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and the business needs. Preparing and submitting regulatory documents like Drug Master Files (DMFs) and marketing authorization applications (MAAs) to regulatory bodies. Preparation and Compilation of dossiers in CTD & eCTD. Collaborating with cross-functional teams to address regulatory queries in a timely manner. Responsible for end-to-end filing of New products (Actives / Fixed Dose Combinations / Nutritional supplements etc.) in CDSCO (Central Drugs Standard Control Organization), FSSAI, State FDA and other re...

We are looking for Regulatory Affairs - Executive / Sr. Executive handling Africa and Asia and will be based at Juinagar, Navi Mumbai. Roles & Responsibilities: 1. 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. 2. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. 3. Regulatory Compliance and Updates: Stay informed of changes in Asian and CIS market regulations, ensuring timely implementation of updates to maintain compliance. Provide ...