115 Anda Jobs - Page 5

Cross-Functional Collaboration: Collaborate with R&D, manufacturing, and marketing teams to integrate regulatory considerations into the product development and commercialization processes. Regulatory Submissions: Oversee the preparation and submission of all necessary regulatory new dossier filings, and variations, to relevant health authorities in the targeted regions. Market Intelligence: Monitor and analyze evolving regulatory landscapes and market trends to proactively identify opportunities and challenges. Stakeholder Engagement: Build and maintain strong relationships with regulatory agencies, industry associations, and key stakeholders to facilitate smooth regulatory processes. Team Leadership: Lead and mentor a diverse team of regulatory professionals, promoting a culture of excellence, compliance, and continuous improvement. Compliance Oversight: Ensure all regulatory activities adhere to internal policies and external regulations, managing audits and inspections effectively.

About the Role We are looking for a highly motivated and results-oriented Marketing campaigns Specialist to join our growing team at Quizizz. In this role, you will be responsible for the execution and deployment of marketing campaigns, including crafting compelling copy, working with designers to create engaging creative, and analyzing results. What You Do Utilize marketing automation tools (e.g., Clevertap, Braze, Moengage) to design, build, and execute automated and manual marketing campaigns across multiple channels Develop and write effective content for all marketing communications. Collaborate with designers to create visually appealing and on-brand marketing materials. Manage campaign execution, including scheduling andA/B testingPossess a deep understanding of events, attributes, SDKs, APIs, and webhooks to ensure seamless data integration. Be resourceful and proactive with a "get things done" attitude. Who You Are 2-3 years of experience in lifecycle or email marketing, with preference for startup experience Proven experience using marketing automation tools (e.g, Clevertap, Braze, Moengage, Klaviyo etc.) Strong copywriting and design skills Experience with campaign execution and management Solid understanding of email marketing best practices Proficiency in data analysis and interpretation Excellent communication and collaboration skills Ability to work independently and manage multiple tasks simultaneously

Role & responsibilities - Review, compile and submit the Application dossiers (ANDA, MAA) to regulatory agencies like US-FDA, EMA, Health Canada, Australia and ROW countries. - Review and approve regulatory CMC documents being generated at R&D and commercial manufacturing facility such as development reports, BMR, BPR, Specifications, method validation reports, process validation reports, stability protocols, stability data etc. and ensure regulatory compliance. - Maintenance of the complete history of each Drug products (Filing history with agencies/customers, amendments).To coordinate in regulatory audits and provide regulatory support. - Coordination with internal and external stakeholders for regulatory filing related documentation. - Communicate the agency's comments/deficiencies to respective in house departments, prepare the response and submit it back to the agency. - Hands on experience of post approval variations and Annual reports. Preferred candidate profile Master of Pharmacy Perks and benefits As per Company Standards

Role & responsibilities l) Perform searches in various databases, short-list relevant patents/applications and prepare patent landscape Reports for identified molecules. 2) Perform FTO and infringement analysis. 3) Design IP compliant formulation development strategies 4) Perform patentability evaluation and drafting patent applications 5) Provide Patent, Exclusivity certification for ANDA filing and patent information for ANDA Submissions. 6)Prepare response to office action & handle prosecution. 7) Coordinate with R&D, other CFTs, external examiners in prosecuting patent applications and help in building patent portfolio. 8) Support the product selection & ideation activity by performing comprehensive analysis of the product including Formulation, PKPD, IPR and Technology Transfer 9) Provide technical support to legal teams during litigation/patent oppositions. 10 ) Provide strategic Il) inputs to R&D, BD & portfolio team, and identify leverage opportunities for value maximization. 11) To frame launch timelines of products for various countries by reviewing the patent landscape and analyzing IP of blocking patents and Exclusivity for commercial launch. 12) Preparing response to the queries raised by clients and Business Development team and internal and external clients. Preferred candidate profile Educational Qualification should be M. Pharma / PhD & LLB. M. Pharm Pharmaceutics. Having 12 to 15 Years Experience. Must Have Experience in New Product Selection & Formulation IPR Perks and benefits As Per Company Standards.

Long Description Conduct IP searches using various databases, e. g. SciFinder, Thomson, USPTO, Espacenet etc. Update the IP searches at regular intervals Prepare IP landscape and note for R&D Conduct weekly IP updates for granted and published IP Conduct IP due diligence for in-licensing /out-licensing dossiers in various geographies Conduct patentability analysis Draft patent applications Communicate with counsel for IP filings Prepare response to office actions Correspondence with regulatory wrt patent certifications, label changes, patent amendments etc Review DDR (Drug Development Report) and PDR (Product Development Report) before DMF and ANDA filing Conduct prior art search for assisting IP challenges Collect discovery documents in patent litigation Legal CI OB changes, citizen/suitability petitions Medical CI for identifying follow-ons Provide IP information for product identification Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Process Excellence Stakeholder Management Strategic Agility Education Masters in Pharmaceutical Chemistry Work Experience 1-4 Years

Job description:- Review of Drug master file (DMF) Evaluation Of analytical Documents - Specifications, method Validations Checking Pharmacopoeial Change with respect to DMF Submissions Familiar with life cycle Management of DMD Changes good command over spoken and written English well Versed with working on computer

Key Responsibilities: Preparation and submission of DMF (Drug Master Files) and other regulatory documents. Handling regulatory queries and compliance with global regulatory agencies. Coordination with R&D, QA, and production teams for regulatory submissions. Maintaining up-to-date knowledge of regulatory guidelines (USFDA, EDQM, TGA, etc.). Ensuring smooth regulatory approvals and post-approval compliance.

Role & responsibilities: Prepare and manage regulatory submissions (e.g., Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), marketing authorization submissions). Ensure clinical trials are conducted in compliance with regulatory requirements, including Good Clinical Practice (GCP), ICH guidelines, and local regulations. Track regulatory timelines and manage submission deadlines for new drug applications, clinical trials, and so on. Preparation and review of clinical study reports along with preparation of Bio summary/summary tables, BTIF and other regulatory documents with the study data. Adhering to GCP to meet regulatory requirements, Verification of deviations from the Protocol, SOPs, GCP and other applicable requirements and taking preventive action and corrective action to prevent recurrence. Preparation of audit reports and suitable corrective and preventive action plans. To have experience in the Ethics Committee related activities. To liaison with Local Drug Authorities (DCGI/CDSCO) for regulatory approvals of Test Licenses, Amendments, for conducting BA/BE clinical studies in India. Timely notification to DCGI/CDSCO for study related updates Communicate with regulatory agencies to clarify requirements and resolve issues related to clinical trial approvals and submissions. Manage responses to regulatory queries and facilitate interactions between the client and regulatory bodies. To search literature on healthy population to support BA/BE NOC application To liaise CBN for regulatory approvals for conducting clinical studies in India. To coordinate with global regulatory authorities for regulatory strategic for various products and services Proactive co-ordination of all the necessary activities required regulatory submission. Preferred candidate profile: Education : Bachelor's degree in life sciences, pharmacy, or related field (Masters or advanced degree preferred). Experience : 5+ years of experience in regulatory affairs within a CRO or pharmaceutical/biotech industry, with at least 2 years in a managerial role. Knowledge : In-depth knowledge of global regulatory guidelines (FDA, EMA, ICH), clinical trial regulations, and submission processes. Interested applicants can apply with their updated profile or Can send to email to hr@qpsbioserve.com

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 salary range based on their U.S. or Canada hiring location. The recruiter can share more details about compensation for the role in your location during the hiring process. U.S. employees have access to quality medical, dental and vision insurance, a 401(k) plan with a Cisco matching contribution, short and long-term disability coverage, basic life insurance and numerous wellbeing offerings. Employees receive up to twelve paid holidays per calendar year, which includes one floating holiday (for non-exempt employees), plus a day off for their birthday. Non-Exempt new hires accrue up to 16 days of vacation time off each year, at a rate of 4.92 hours per pay period. Exempt new hires participate in Cisco s flexible Vacation Time Off policy, which does not place a defined limit on how much vacation time eligible employees may use, but is subject to availability and some business limitations. All new hires are eligible for Sick Time Off subject to Cisco s Sick Time Off Policy and will have eighty (80) hours of sick time off provided on their hire date and on January 1st of each year thereafter. Up to 80 hours of unused sick time will be carried forward from one calendar year to the next such that the maximum number of sick time hours an employee may have available is 160 hours. Employees in Illinois have a unique time off program designed specifically with local requirements in mind. All employees also have access to paid time away to deal with critical or emergency issues. We offer additional paid time to volunteer and give back to the community. Employees on sales plans earn performance-based incentive pay on top of their base salary, which is split between quota and non-quota components. For quota-based incentive pay, Cisco typically pays as follows: .75% of incentive target for each 1% of revenue attainment up to 50% of quota;

Skill required: Pharmacovigilance Services - Customer Acquisition Strategy & Implementation Designation: Deputy General Manager Pharmacovigilance Services Qualifications: Bachelor of Pharmacy Years of Experience: 5 to 8 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 world's leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Support in the context of public disclosure of clinical documents in accordance with client and Regulatory requirements as communicated by the client. Clinical documents should be redacted to protect the privacy of individuals, groups, and staff associated with a clinical study so that these documents can be made available for public, post approval from EU and US regulatory authorities. Privacy data should be removed or redacted from the clinical documents before public disclosure per the Redaction Checklist. Quality review of redacted clinical documents per specific guidelines. Finalization of the fully redacted documents Ensure to complete the task including redaction and incorporation of QC comments in clinical documents within the agreed timelines. Must be well versed with EU Policy 70 and Health Canada guidelines on clinical trial data transparency. Should have thorough knowledge of redaction and anonymization techniques. Well versed in preparation of anonymization report and justification tables. What are we looking for? Ability to establish strong client relationship Ability to manage multiple stakeholders Ability to meet deadlines Ability to perform under pressure Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts

Job Title Payments - GPP Responsibilities Global Pay Plus Testers. MT MX messaging , SWIFT payments Preferred Skills: Banking->GPP Financial Services Domain->Payments->GPP Generic Skills: Banking Educational Requirements Bachelor of Engineering Service Line Infosys Quality Engineering * Location of posting is subject to business requirements

Job Title Payments - GPP Responsibilities Global Pay Plus - Payments Technical and Professional Requirements: Payments:ISO-20022 standards SWIFT, SEPA, MT messages Preferred Skills: Banking->GPP Financial Services Domain->Payments->GPP Generic Skills: Banking Educational Requirements Bachelor of Engineering Service Line Infosys Quality Engineering * Location of posting is subject to business requirements

Job Title - Platforms Senior Manager Level- Senior Manager- S&C GN-CFO&EV Management Level:06 Senior Manager Location:Gurgaon, Mumbai, Bangalore, Pune, Hyderabad Must have skills:SAP FICO Implementation Good to have skills:Generic FICO, PS+Investment mgt, DRC, FSCM, CO, VIM+FI, OCR, Functional MDG, AFC/FCC, SAP ICMR, Intercompany, SAP CFIN Experience:15-18 years Educational Qualification:MBA(Finance) or CA or CMA Job Summary : Have been part of at least 6 end to end SAP implementations. Out of which 3+ in S4 Understand the SAP roadmap for S/4 HANA and become a trusted advisor for clients in driving their S/4 HANA adoption. Have experience in defining a Business Case for S4 Transformation and RoI calculations. Have worked in the capacity of Solution Architect / Design Authority in Past and have done lot of advisory work for ERP's for e.g. Product selection, Value realization, Fit Gap Assessment etc. Work closely with clients to understand their issues, define IT strategies, architecture solutions, win buy-in for your recommendations. Drive sales pipeline and independently own proposals related to Finance / Multi-function S/4 HANA engagements. Lead and transform the consulting industry by developing some key Assets and Accelerators which can help Clients in their digital transformation journey. Provide direction for complex SAP S/4 HANA issues, and can collaborate with the business and developers and execute on agreed timelines. Provide consulting solutions including how to leverage standard SAP S/4 HANA functionality and how to enable requirements while maximizing the ROI Lead intelligent conversations to guide clients through best-practice project scoping and delivery to ensure overall project success in implementing SAP S/4 HANA Have ability to manage project execution and manage client conversations during assessment, design, implementation, and status reporting Lead the problem solution design and implementation ensuring high quality adhering to the timelines and defined budget Supervision of Accenture Managers, Senior and Junior analysts and consultants and client personnel to drive delivery outcomes. Roles & Responsibilities: Should know how to lead and deliver S/4 HANA engagements across different implementation approaches including excellent understanding of client business processes, pain points, S/4 HANA solution options and organization structure Should know how to drive and build sales pipeline including BDs and Proposals Should be aware of digital finance technologies that drives business processes Should know how to lead business case creation for SAP design to implementation projects Drive continuous improvement capability with regards to methodology, tools, practices and maturity Professional & Technical Skills: MBA from a Tier-1 or Tier-2 B-school. CA or CPA Deep knowledge and experience in Finance and Controlling Org structure and design, S/4 HANA Implementation and rollout point of views, approach and design principles, roadmap, and business case definition. Ability to drive large scale digital finance transformation initiatives during the entire life cycle of the project. 15+ years' experience in SAP S/4 HANA design to implementation projects At least 8+ years of consulting experience in a big4 or similar firms Extensive experience in GTM/Presales and writing proposals. Programme management experience and track record of successful (on-time & on-budget) delivery of large, complex programs in a dynamic environment with numerous and complex stakeholders' groups Active role in the identification of opportunities by farming existing relationships and growing new networks. Ability to work independently with minimal supervision and lead global distributed teams Additional Information: An opportunity to work on transformative projects with key G2000 clients Potential to Co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everything"from how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge and capabilities Opportunity to thrive in a that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. Qualifications Experience:15-18 years Educational Qualification:MBA(Finance) or CA or CMA

Key Responsibilities Support supervisor for End-to-end coordination for all projects, interacting with the API vendors and internal teams (Analytical, formulation, Regulatory, QA/QC) to resolve all technical concerns (Documents/analytical issues/material quality) and fulfil requirements for ANDA submission and Regulatory Agency deficiencies, along with Global launch for US and non-regulated markets. Use technical knowledge to perform in-depth review of API drug master file as per current US FDA expectations; identify deficiencies and formulate strategies to resolve them. Close coordination with Packaging material and Excipient vendors, placing orders, arranging technical documents to Analytical and Regulatory team s satisfaction, resolving ARD/QC s technical issues by discussion with Raw material vendors Understanding the impact of changes in Raw material process/specifications and preparation of Change controls and coordinating with internal teams for timely closure Work across multiple time-zones to be in regular contact with global suppliers and cross functional teams within the organization for seamless project management. Routine tracking of all shipment against orders and updating to internal team Actively organize and lead teleconferences with key stakeholders to monitor the progress, identify and resolve key issues for successful execution of projects. Data management for all relevant projects handled within the team Keep up-to-date with the changing market dynamics and FDA regulatory guidelines in the US Generic Industry.

Labour and Employment Law Legal Team Associate Manager / Manager Description About Entity: Corporate Functions"including Human Resources, Finance, Legal, Marketing Communications, and Workplace Solutions-- powers Accenture's people across industries and functions to keep our business leading in the New. Join the heart and soul of Accenture, partnering with our extraordinary people to bring innovation into every organization. Job description: Labour & Employment Counsel Associate Manager Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, Accenture offers Strategy and Consulting, Technology and Operations services and Accenture Song"all powered by the world's largest network of Advanced Technology and Intelligent Operations centres. Accenture India has operations in 14 cities across India and have more than 300k employees spread across these locations. Requirement: We are looking for 2 lawyer for position of Associate Manager (equivalent to a Deputy Manager in industry parlance) in the Employment Law (India) Legal Group Reporting will be to Senior Manager / Associate Director [Legal] Employment Law which is a part of Operations, Regulatory and Ethics (CORE) Legal, supports a broad portfolio and supports the Delivery Centres, in end-to-end operations. Internal clients range from Employee Relations, HR, Recruitment, Workplace, Global Asset Protection (GAP), Marketing and Communication (Marcom), and Government Relations. Role Description: This role is broad and could involve providing advice on various facets of legal and employment areas and demands an understanding of Indian labour laws, laws relating to investigations (misconduct, POSH and others), and court proceedings etc. Focus for the current position is as follows: Role Description: Advisory Services: Provide legal guidance on employment-related issues in India, including hiring practices, employment contracts, misconduct, discrimination, harassment, employee benefits, termination procedures etc. Proactively assess and mitigate employment legal risks. Employment Disputes and Litigation: Manage employment-related disputes, claims, and litigation in tribunals and courts, including wrongful termination, discrimination claims, and wage disputes. Collaborate with external legal counsel to strategize and achieve optimal outcomes. Legal Drafting: Prepare written statements and responses to claims, conduct comprehensive legal research to support case strategies, and stay abreast of recent case laws and legal precedents in labour and employment law. Sexual Harassment Law: Provide advice on matters related to the Prevention of Sexual Harassment (POSH) Act. Policy review: Collaborate with stakeholders to develop, review, and implement employment policies and procedures that comply with local laws and align with the organization's values. Regulatory Monitoring: Monitor changes in employment laws and regulations, assess their impact on the organization, and recommend proactive measures to ensure compliance and mitigate potential risks. Labour Compliance: Ensure adherence to labour laws and regulations, including the Shops and Establishments Act. Sexual Harassment Law: Provide advice on matters related to the Prevention of Sexual Harassment (POSH) Act. Key Skills: Review employee matters, analyse and asses possible and suggest mitigations measures. Court experience and proficiency in drafting legal documents and court submissions Strong legal research and analytical skills with in-depth knowledge of Indian labour laws and regulations Clear communication and interpersonal skills High attention to detail and exceptional organizational skills. Qualifications Education and Experience Requirements Required LLB 6 + years relevant work experience