398 Anda Jobs - Page 9

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...

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

About The Role Skill required: Talent Acquisition - Sourcing & Screening - Strategic Talent Sourcing Designation: Candidate Source & Screen Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years What would you do? Improve workforce performance and productivity, boosts business agility, increases revenue and reduces costsYou will be aligned with our Recruitment vertical. Our services span across the entire accountable for the delivery of candidates to meet the recruiting demand based on the Recruiting Plan. Employees under this span will be a part of one of the sub-offerings - Recruitment , Sourcing , Scheduling , BGV , Document Collection , Onboarding & Internal Shar...

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 / ...

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,...

Compile, prepare, review and submit ANDA submissions and Amendments to FDA with an overall objective to avoid major deficiencies and contribute to get approval within the shortest timeframes possible. Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met. Must have expertise/prior experience in Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage form ANDAs either with Aseptic sterilization or Terminal sterilization or both techniques. Ensure timely submission of all assigned projects. Review / prepare documents which meet the requirement set forth by US FDA and accept...

Message to applicants applying to work in the U.S. and/or Canada: When available, the salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. and/or Canada locations, not including equity or benefits. For non-sales roles the hiring ranges reflect base salary only; employees are also eligible to receive annual bonuses. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidates hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full sala...

Role & responsibilities Review and authorize change controls, assessing their impact on regulatory submissions. * Coordinate and organize meetings with cross-functional teams to discuss IRs, DRLs, and CR letters from agencies; circulate Minutes of Meeting (MoM) and follow up on action items. * Compile and coordinate high-quality CMC regulatory submissions for the US market in compliance with current regulatory guidelines and timelines. * Assess change controls from formulation plants and categorize them based on risk to product quality and compliance. * Plan, review, and submit CBE, CBE-30, and Prior Approval Supplements (PAS). * Draft high-quality responses to regulatory agency letters (IR,...

As the Manager of India OSD Pre-approval ANDA portfolio, Injectable Drug Substance pre-approval portfolio, and Global DMF Review portfolio, your primary responsibilities involve providing Drug substance/nitrosamine review support to complex projects, including 505(b)(2), Europe & Canada projects. You will also participate in cross-functional meetings to address regulatory/technical issues and facilitate decision-making processes. Additionally, it is essential to engage with API vendors to gather relevant information and prevent any deficiencies in Drug Substance. Your role also encompasses bridging DMF/API related regulatory decisions between Raks & Amneal Teams, conducting training sessions...

About The Role : Job TitleCorporate Trust - Debt & Agency, Analyst LocationMumbai, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services, and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. Trust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at Deut...

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...

We are looking for a young and talented individual to market our specialized products within the travel agents network in Maharashtra & Gujarat People with prior experience within the travel industry , specifically looking into channel sales will be preferred The job will require traveling within Mumbai & the states of Maharashtra & Gujarat Our Major Products will include Ladakh tours for the Summer along with Europe & Sri Lanka tour products

Incoda Media is looking for Assistance Manager / Manager - Media 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 company€™s 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 a...

Key Responsibilities 1. Executive Support Manage and prioritize the executives calendar, ensuring optimal use of time across time zones Schedule internal and external meetings, organize travel logistics, and coordinate accommodations Handle email, phone, and other communications with discretion and professionalism Prepare executive-level presentations, reports, and documentation for business reviews and leadership meetings Manage expense reports and provide end-to-end administrative support 2. Special / Strategic Project Support Assist in driving special projects, ensuring timelines and deliverables are metTrack project milestones, identify bottlenecks, and coordinate with stakeholders for t...

IP evaluation of Formulation & Drug-Device combination products. Claim chart preparation, Structuring FLBs & supporting Litigation. IP creation via Patent filing for our 505(b)2 range of products. Provide IP support to Central Portfolio Team for USA & International Market. IP Support & Due diligence involving new business opportunities. IP creation via Patent filing for our 505(b)2 range of products. Track pending patent applications/OB listings/Competitors ANDA & litigation strategy, assessing the impact on our pipeline - keep Sr. Management informed.

: Prepare and review Peptide API Drug Master Files (DMFs) for submission to the US FDA and other regulatory agencies. Handle deficiency responses and interact with regulatory authorities for query resolution and clarification. Prepare and manage ANDA Drug Substance Modules and support associated submissions and updates. Compile and submit DMFs, and support any lifecycle management or post-submission queries. Maintain current knowledge of regulatory guidelines and ensure regulatory compliance across all submissions. Participate in internal and external project discussions and contribute to the preparation of regulatory project presentation slides and documentation. Ensure coordination between...

Educational Requirements Bachelor of Engineering Service Line Infosys Quality Engineering Responsibilities Global Pay Plus Testers. MT MX messaging , SWIFT payments Preferred Skills: Banking-GPP Financial Services Domain-Payments-GPP Generic Skills: Banking

Role & responsibilities 1. Characterization of RLD pack samples. 2. Finalization of packing configuration for Exhibit batch packing of new generic product/NDA as per requirement. 3. Identification of new packaging material & new vendor development for packaging materials. 4. Mold development for primary packaging material & secondary packaging material & its validation. 5. Support to Regulatory team on ANDAs/NDA’s filling for regulated market. 6. Coordination with NPI & planning team for launch of ANDA’s/NDA’s. 7.Preparation & revision of packaging material specification. 8. Preparation & review of MPC, FMEA, TA, DHF & AFMEA. 9. Preparation & review of Development Study protocol & report & e...

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....

Message to applicants applying to work in the U.S. and/or Canada: When available, the salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. and/or Canada locations, not including equity or benefits. For non-sales roles the hiring ranges reflect base salary only; employees are also eligible to receive annual bonuses. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidates hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full sala...

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...

Roles and Responsibilities Prepare ANDA dossiers, CMC modules, and submission documents for US FDA approval. Post approval and life cycle management of approved ANDA & suppliment filling. Review and prepare labeling documents (labels, cartons, pack insert) according to US regulations. Develop expertise in various therapeutic areas such as Cardiology, Diabetology, Neurology, Ophthalmology etc. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Ensure timely submission of applications to USFDA while maintaining high-quality standards. Desired Candidate Profile 8-10 years of experience in Regulatory Affairs with a focus on US market. Bachelor's degree in ...