202 Ectd Jobs - Page 3

Role & responsibilities Responsible to assess customers requests for Letters of Authorization (LOA) to reference Drug Master Files (DMFs) Issue LOAs for US-FDA, Health Canada and NMPA China. Maintain LOA data base, prepare analysis and share with the sales teams as required Prepare weekly data packages for DMFs & support RA Manager for the annual reports of all DMFs Responsible for the availability of annual washing validation reports of all healthcare sites, review reports and transform into submissions formats. Arrange samples and testing data required for submission Support RA Manager in preparation of dossiers and preparing response to the Health Authorities Manage timely notarization an...

Biostatistician cum Statistical Programmer Job Description Performs biostatistical and SAS programming activities for given clinical trials involving Novel, Biosimilar and PMS studies. As a Biostatistician cum Statistical Programmer youll work on a variety of projects, while collaborating with our cross-functional team of experts. Youll be able to develop your statistical skills, gain exposure to multiple therapeutic areas. Youll also contribute to research design and analytical strategies, provide input into protocols, Statistical Methodology and develop and review statistical analysis plans. As a Statistical Programmer, you will leverage your SAS programming skills to support Phase I-IV cl...

Experience working in the company that provides software solutions to life sciences industry (pharma, CRO) with a solid understanding of pharmacovigilance Good understanding on pharmacovigilance, safety and clinical guidelines Strong Experience in identifying, analyzing and translating business requirements into solutions Knowledge on case processing, workflow, Validation rules Strong experience in Bug Life cycle management and its tools Hands-on experience on R2 and R3 XML files Good Oral and written communication skills, excellent attitude Roles and Responsibilities Will be responsible to understand the requirements, translate those requirements into test scripts Write test plan, write tes...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operati...

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

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operati...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Master of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by c...

Our Ideal Candidate: Our ideal candidate will typically be expected to demonstrate the following attributes: Good technical knowledge in Oracle Cloud Infrastructure Knowledge & working experience in ExaCS Understanding of Technical architecture landscape Should have a strong customer facing skills Ability to multitask, maintain composure in high-stress/high-visibility situations and change priority as needed to accommodate very dynamic business. Excellent team player, willing to learn new technologies Strong organization skills, detail oriented & communication skills. . University degree, with post graduate technical or management qualifications or other relevant experience. OCI Certified / ...

Role Overview The Sr. Associate IS Analyst DocuBridge will play a critical role in the implementation, support, and lifecycle management of structured regulatory submission solutions, primarily focused on Lorenz DocuBridge. This position requires strong technical and regulatory knowledge, project execution capabilities, and hands-on system expertise. The candidate will work closely with Regulatory Affairs, IT, Quality Assurance, and vendor partners to deliver compliant, efficient, and scalable submission systems aligned with global health authority requirements. Roles & Responsibilities Support the implementation and system management of the Lorenz DocuBridge Suite, ensuring alignment with g...

Lead Analyst- Emerging Markets Strategy: Elevate Your Impact Through Innovation and Learning Evalueserve is a global leader in delivering innovative and sustainable solutions to a diverse range of clients, including over 30% of Fortune 500 companies. With a presence in more than 45 countries across five continents, we excel in leveraging state-of-the-art technology, artificial intelligence, and unparalleled subject matter expertise to elevate our clients' business impact and strategic decision-making. Our team of over 4, 500 talented professionals operates in countries such as India, China, Chile, Romania, the US, and Canada. Our global network also extends to emerging markets like Colombia,...

Summary Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements Ensures compliance to the requirements from regulatory agencies Maintains the technical and non-technical documentation change system Assures procedures are in place to classify and maintain records Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers May analyze and evaluate data, extract pertinent information, prepare information ab...

Job Purpose and Impact The Business Analyst - HR Core will lead efforts through influence that will enable change in an organizational context through the creation of the definition of the business needs and the creation of solution recommendations that deliver value to stakeholders. In this role, you will use advanced knowledge of the tasks and techniques that are used to perform complex business analysis such as solution evaluation, strategy analysis, elicitation and collaboration, requirement life cycle management, requirements analysis and design definitions and business analysis planning and monitoring to advance the profitability or efficiency of the business. You will partner effectiv...

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Contract Management Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :Contract Lifecycle Management (CLM) Subject Matter Expert (SME) is someone with deep knowledge and experience in using CobbleStone's Contract Insight software to manage the entire contract lifecycle. This includes tasks like contract requests, authoring, negotiation, approval, execution, management, and renewal. They understand the system's features, configurations...

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 : Contract Management Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :Contract Lifecycle Management (CLM) Subject Matter Expert (SME) is someone with deep knowledge and experience in using CobbleStone's Contract Insight software to manage the entire contract lifecycle. This includes tasks like contract requests, authoring, negotiation, approval, execution, management, and renewal. They understand the system's features, configurations...

Key Responsibilities: Dossier Compilation: Prepare, compile, and review regulatory submissions (CTD/ACTD format) for ROW & emerging markets. Work on Module 1 (administrative/legal), Module 2 (summaries), and Module 3 (quality) for OSD products. Ensure dossier accuracy, completeness, and alignment with country-specific requirements. Regulatory Compliance: Ensure all documentation complies with ICH , WHO , and respective country-specific guidelines . Maintain awareness of evolving regulatory requirements across ROW markets. Coordination & Liaison: Coordinate with internal teams: QA, QC, Production, Packaging, and F&D for data collation. Liaise with external stakeholders like regulatory consult...

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Scienc...

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...

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries....

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 .

Develop tablet/capsule formulations for regulated markets (US/EU). Conduct pre-formulation, prototype trials, and scale-up. Execute lab, exhibit, and validation batches. Prepare technical documents for ANDA filings. Support tech transfer and respond to regulatory queries.

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 ...

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...