581 Ctd Jobs - Page 2

Job Responsibilities- Assisting in developing audit planning documentation addressing scope,auditobjective, budgeted hours, resource plan,and reporting date Complete assignedaudits, addressing allauditobjectives, conducting clientandstatus meetings as required, controlling, monitoring,and reporting onauditprogress, reviewing work papers,and ensuring work papers provide adequate support of conclusions while complying with internal standards for documentation. To monitor the assignment for improving the efficiency of the assignment, manageauditin relation to time and resource budget Will actively check that all findingsandissues are documentedandperform closedown procedures Gatheringandcompili...

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...

Coordinate and prepare regulatory submissions, including applications, reports, and other documents.Ensure compliance with relevant laws, regulations, industry standards.Develop and maintain relationships with regulatory authorities Required Candidate profile Strong knowledge of regulatory submissions, compliance, and industry standards.Excellent communication and interpersonal skills.Ability to work independently and as part of a team.

Coordinate regulatory submissions and ensure compliance with relevant laws and regulations.Prepare and review regulatory documents, including applications and reports.Collaborate with cross-functional teams to meet regulatory requirements. Required Candidate profile Strong knowledge of employment firms and recruitment services.Excellent communication and coordination skills.Ability to work effectively in a fast-paced environment.

Publish regulatory submissions to relevant authorities, ensuring compliance with required standards and regulations.Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Required Candidate profile Strong understanding of employment firms and recruitment services.Excellent publishing skills, with attention to detail and ability to meet deadlines.Ability to work independently

Coordinate and prepare regulatory submissions, including applications, reports, and other documents.Ensure compliance with relevant laws, regulations, and industry standards. Required Candidate profile Strong knowledge of regulatory submissions, compliance, and industry standards.Excellent communication and interpersonal skills.Ability to work independently and as part of a team.

8 years experiences for RA role in medical device and or pharmaceutical industry.Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements. Required Candidate profile Desired Skills:RA role in medical device, US FDA and EU. Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare related majors.

Procurement Operations: Source and procure raw materials (APIs, excipients), packaging materials, and other pharma-related items. Evaluate purchase requisitions and coordinate with internal departments (production, QA/QC, R&D) to ensure timely procurement. Issue purchase orders (POs) and track their status until delivery and GRN. Vendor Management: Identify, evaluate, and develop new suppliers and maintain strong supplier relationships. Negotiate prices, payment terms, delivery schedules, and contracts. Monitor vendor performance based on quality, cost, delivery, and service. Inventory & Cost Control: Coordinate with the inventory team to maintain optimum stock levels. Analyze and control pr...

ONLY EXPERIENCE CANDIDATE CAN APPLY Job description: - We are looking for a Regulatory Affairs Executive with strong knowledge of pharmaceutical products. The candidate must have experience in domestic regulatory compliance (FSSAI/CDSCO) and export documentation , specifically for LATAM & ROW. Responsibilities include dossier preparation, label review, and coordination with departments for regulatory submissions. Key Responsibilities: 1. Handle regulatory documentation and submissions for Pharmaceutical Products (domestic & export). 2. Prepare dossiers, technical files, and product registrations as per domestic (FSSAI, CDSCO & Etc.) and international regulations . 3. Ensure products comply w...

Handle customer inquiries and resolve issues professionally.Provide excellent customer service through various communication channels.Develop and maintain strong relationships with customers. Required Candidate profile Strong communication and interpersonal skills. Ability to work in a fast-paced environment and adapt to changing situations. Proficient in French, US/Canada shift, and other languages as required.

Coordinate and prepare regulatory submissions, including applications, reports, and other documents.Ensure compliance with relevant laws, regulations, and industry standards.Develop and maintain relationships Required Candidate profile Strong knowledge of regulatory submissions, compliance, and industry standards. Excellent communication and interpersonal skills. Ability to work independently and as part of a team.

Develop high-quality regulatory documents, including clinical trial applications and marketing authorizations.Collaborate with cross-functional teams to ensure compliance with regulatory requirements Required Candidate profile Minimum 2 years of experience in regulatory writing, preferably in the pharmaceutical or healthcare industry. Strong understanding of regulatory requirements, including FDA, EMA, and ICH guidelines.

Develop and implement regulatory compliance programs to ensure adherence to industry standards.Publish regulatory documents, such as reports and updates, on time and accurately. Required Candidate profile Strong knowledge of regulatory compliance principles and practices. Excellent writing and publishing skills, with attention to detail and accuracy.

Develop high-quality regulatory documents, including clinical trial applications and marketing authorizations. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Required Candidate profile Minimum 2 years of experience in regulatory writing, preferably in the pharmaceutical or biotechnology industry. Strong understanding of regulatory requirements,

Coordinate and manage shipping operations, including arranging transportation and logistics.Develop and maintain relationships with clients, suppliers, and other stakeholders.Prepare and review shipping documents Required Candidate profile Strong knowledge of shipping regulations, laws, and practices. Excellent communication, negotiation, and problem-solving skills. Ability to work in a fast-paced environment and meet deadlines.

Manage shipping operations for timely and efficient delivery. Coordinate with logistics teams to resolve issues and enhance service quality. Develop and implement strategies to improve shipping costs and reduce delays. Required Candidate profile Minimum 5 years of experience in shipping or logistics management. Strong knowledge of shipping regulations and industry standards. Excellent communication and problem-solving skills.

Coordinate and manage shipping operations, including arranging transportation and logistics. Develop and maintain relationships with clients, suppliers, and other stakeholders. Prepare and review shipping documents. Required Candidate profile Strong knowledge of shipping regulations, laws, and practices. Excellent communication, negotiation, and problem-solving skills. Ability to work in a fast-paced environment and meet deadlines.

Responsibilities. Global Product Registration & Dossier Management Lead the full registration lifecycle (pre-market research, submission, renewal) for all target export countries. Compile regulatory dossiers, including 5-batch analysis and efficacy data, ensuring strict adherence to national formats. Serve as the primary Point of Contact (POC) to coordinate data between R&D, factory, customers, and regulatory authorities for seamless submissions. Compliance and Policy Monitoring Monitor global regulations (e.g., MRLs, restrictions) and communicate changes to ensure continuous company compliance. Verify GLP/quality compliance of all required efficacy, toxicity, and environmental studies prior...

Responsibilities: Compilation and review of regulatory dossiers (CTD, ACTD, eCTD) for CIS, LATAM (especially Brazil & Mexico), African, and EU regions. Handle full lifecycle of product registration including new submissions, renewals. Review technical documentation: PDR, DMF, AMV, BMR/BPR, Specifications, Stability Reports, BE Studies, etc. Address Ministry of Health (MoH) queries and manage deficiency responses. Manage post-approval changes and variation submissions. Liaise with international regulatory agents and distributors for submission coordination. Artwork review and approval ensuring compliance with label regulations. Maintain up-to-date registration database and submission tracker....

Coordinate regulatory submissions and ensure compliance with relevant laws and regulations. Prepare and review regulatory documents, including applications and reports. Collaborate with cross-functional teams to meet regulatory requirements. Required Candidate profile Strong knowledge of employment firms and recruitment services. Excellent communication and coordination skills. Ability to work effectively in a fast-paced environment. Strong analytical skills.

Position Purpose Provide a brief description of the overall purpose of the position, why this position exists and how it will contribute in achieving the teams goal. Responsibilities Direct Responsibilities Preparation of Compliance Documents for recertification 1.1 Recertify the KYC forms (Due Diligence Package) for completion, 1.2 Obtain mandatory documents and reports as per KYC requirements 1.3 Perform necessary checks (3rd parties, website, and stock exchange) to complete the recertification preparation, including checks against local and global blacklists. 1.4 Contact SBO to collect missing documents, opinions and sign off 1.5 Get KYC forms and mandatory documents validated by onshore ...

Join our team! Were building a world where Identity belongs to you. We are seeking a detail-oriented and proactive Payroll Analyst to join our Finance Global Capability Center (FGCC) team in Bangalore. This role is critical to supporting accurate and timely processing of payroll across Oktas international, including countries in Europe and Asia-Pacific. The ideal candidate will have a strong understanding of end-to-end payroll processes, excellent coordination skills to work with regional payroll teams, global payroll vendors and other internal stakeholders, and the ability to navigate complex compliance and statutory requirements in different geographies. Key Responsibilities Support the ti...

We are looking for a skilled professional with 2 to 6 years of experience to join our team as an Indian Cuisine expert. The ideal candidate will have a strong background in the culinary industry, particularly in Indian cuisine. Roles and Responsibility Develop and implement new menu ideas and recipes to enhance the authenticity of Indian cuisine. Conduct research on different types of Indian cuisine and their regional variations. Collaborate with cross-functional teams to ensure seamless service delivery. Provide exceptional customer service by understanding and addressing guests' preferences and dietary requirements. Maintain high standards of food quality, presentation, and safety. Stay up...

Responsibilities: * Manage regulatory compliance for Row Market products using CTD format under ICH guidelines. * Ensure timely submission of dossiers and variations in accordance with regulations.

Drug Regulatory Affairs will be responsible for compiling, reviewing, and submitting dossiers and regulatory documents for drug product approvals in international markets. Prepare, review, & submit (CTD/eCTD/ACTD formats) for new drug applications. Required Candidate profile B.Pharm/ M.Pharm in Life Sciences. 2–5 years of experience in Regulatory Affairs Knowledge of national and international regulatory (ICH,WHO,USFDA). Exp with dossier preparation in CTD/eCTD format.