Regulatory Operations Associate II

2 days ago


Pune, Maharashtra, India Fortrea Full time
Job Description

- Prepare, compile & review product quality (CMC) & other regulatory documents to support product development or submissions to various countries across the world for product registrations or post approval life cycle maintenance.
- Create and/or revise raw material and packaging specifications, and other associated documents.
- Coordinate and interact with cross functional teams/departments for evaluation/impact assessment of change control, review implementation strategy and required documentation governing the change and manage OOS, OOT or other product related changes.
- Support Financial Data Management, Business Plan file creation and maintenance, Supplier data management and PO creation as required.
- Support for creation and update of global labeling documents, QC and other associated activities for the labeling projects
- Support stability data evaluation & report preparation, dissolution profile evaluation etc.
- Perform literature survey and preparing of various regulatory documents in support of excipients, APIs and/or drug products.
- Coordinate with stakeholders to understand and support import license requirements, investigation report drafting, record management and document coordination with internal and external department.
- Responsible for specifications setting/justification, ensuring the Quality level for Laboratory support, perform Computerized System Validation (CSV) and upgradation of existing systems/software.
- Seek guidance from other team members and manager as needed, and keep up to date knowledge of various regulatory guidelines required for pharmaceutical product registration and product life cycle maintenance.
- Implement use of consistent, efficient, and quality processes to meet timelines and deliverables according to regulatory requirements standard operating procedures and maintain a culture of high customer services.

Learn more about our EEO & Accommodations request here.

  • Pune, Maharashtra, India Fortrea Full time

    Company OverviewFortrea is a dynamic and innovative company dedicated to providing top-notch products and services. Our team of experts works tirelessly to ensure the highest quality standards are met in every aspect of our operations.About the RoleWe are seeking an experienced Regulatory Operations Associate II to join our team. This role will be...


  • Pune, Maharashtra, India Antal International Full time

    Role - IT Operations Engineer IIExperience - 3 to 5 yearsNP - Immediate to 30 daysLocation - Pune (5 days WFO)Key Skills - IT Operations, SQL, Unix, Shell Scripting, Production Support, Service Delivery, Incident ManagementDomain - Candidate should have experience of working in Payments/Cards/Banking domain.As part of the activities of HPS payment services,...

  • cra ii

    4 weeks ago


    Pune, Maharashtra, India Lifelancer Full time

    Job Title: CRA II Job Location: India Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Mid-Senior level DescriptionClinical Research Associate IISyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial...


  • Pune, Maharashtra, India Lifelancer Full time

    Job Title: Biostatistician II FSP Job Location: India Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Job DescriptionWho Are You? A Biostatistician II with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support Phase I-IV clinical studies. You are...


  • Pune, Maharashtra, India BNY Full time

    Associate, Fund Administration IIAt BNY, our culture empowers you to grow and succeed. As aleading global financial services company at the center of theworld's financial system we touch nearly 20% of the world'sinvestible assets. Every day around the globe, our 50,000+employees bring the power of their perspective to the tableto create solutions with our...


  • Pune, Maharashtra, India Capgemini Full time

    Capgemini is on the lookout for a dynamic and detail-oriented Insurance Contact Center Service Operations Excellence Analyst/Project Manager to join our team supporting a top 10 US Insurance Carrier.This role will be critical in enhancing operational effectiveness and improving service delivery in the contact center environment. You will manage projects that...


  • Pune, Maharashtra, India Avient Full time

    Job Summary : The Regulatory Specialist operates within the Product Stewardship team who are responsible for managing all regulatory matters for the global business, liaising with all global company locations and customers in Europe, Asia, North America and Latin America.The Regulatory Specialist will support in the development, implementation and...

  • Senior Associate

    4 weeks ago


    Pune, Maharashtra, India Indigenesis Consulting Pvt. Ltd Full time

    Senior Associate - Tax & Regulatory Services Responsibilities include but not limited to:M&A Taxation:- Advising on structuring for M&A transactions, corporate restructurings, and inbound/outbound investments- Evaluating tax implications of business structuring and investments - Handling direct tax submissions and litigation matters with income tax...

  • Software Engineer Ii

    3 weeks ago


    Pune, Maharashtra, India Allstate Full time

    At Allstate great things happen when our people work together to protect families and their belongings from lifes uncertainties And for more than 90 years our innovative drive has kept us a step ahead of our customers evolving needs From advocating for seat belts air bags and graduated driving laws to being an industry leader in pricing sophistication ...


  • Pune, Maharashtra, India LifeMagic Group Full time

    Job Summary: We are seeking a highly motivated and detail-oriented Operations Associate to join our team in Pune, India. As an Operations Associate, you will be responsible for supporting the day-to-day operations of our organization, ensuring the smooth execution of projects, and providing administrative support to the team.


  • Pune, Maharashtra, India PeopleLogic Business Solutions Pvt Ltd Full time

    Role : Security Operations Engineer II - Data Loss Prevention (DLP). Location : Pune, MH (Local candidates preferred). Experience : 6 to 10 Years. Job Description : - Review and manage DLP alerts.- Conducts DLP event investigations and provides escalation management.- Identifies DLP ruleset tuning opportunities and communicates the recommendations.-...


  • Pune, Maharashtra, India PeopleLogic Business Solutions Pvt Ltd Full time

    Role : Security Operations Engineer II - Data Loss Prevention (DLP). Location : Pune, MH (Local candidates preferred). Experience : 6 to 10 Years. Job Description : - Review and manage DLP alerts.- Conducts DLP event investigations and provides escalation management.- Identifies DLP ruleset tuning opportunities and communicates the recommendations.-...


  • Pune, Maharashtra, India ScaleneWorks Full time

    Job Title: Security Operations Engineer II Data Loss Prevention (DLP) About the Role: We are seeking a skilled and dedicated Security Operations Engineer II with a focus on Data Loss Prevention (DLP) to join our dynamic team. In this role, you will be responsible for implementing and managing DLP solutions, responding to security incidents, and ensuring...


  • Pune, Maharashtra, India myGwork Full time

    This job is with FIS, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Position Type : Full time Type Of Hire : Experienced (relevant combo of work and education) Education Desired : Bachelor...

  • Operations Associate

    4 weeks ago


    Pune, Maharashtra, India LifeMagic Group Full time

    Job Title: Operations AssociateLocation: Pune, IndiaJob Type: Full-timeJob Summary:We are seeking a highly motivated and detail-oriented Operations Associate to join our team in Pune. As an Operations Associate, you will be responsible for supporting the day-to-day operations of our organization, ensuring the smooth execution of projects, and providing...


  • Pune, Maharashtra, India LifeMagic Group Full time

    Job Title Operations AssociateLocation Pune IndiaJob Type Full-timeJob Summary We are seeking a highly motivated and detail-oriented Operations Associate to join our team in Pune As an Operations Associate you will be responsible for supporting the day-to-day operations of our organization ensuring the smooth execution of projects and providing...

  • IP Analyst II

    4 weeks ago


    Pune, Maharashtra, India Lear Corporation Full time

    Lear, a global automotive technology leader in Seating and E-Systems, enables superior in-vehicle experiences for consumers around the world. Our diverse team of talented employees in 38 countries is driven by a commitment to innovation, operational excellence, and sustainability. Lear is Making every drive better by providing the technology for safer,...

  • IP Analyst II

    2 weeks ago


    Pune, Maharashtra, India Lear Corporation Full time

    Lear, a global automotive technology leader in Seating and E-Systems, enables superior in-vehicle experiences for consumers around the world. Our diverse team of talented employees in 38 countries is driven by a commitment to innovation, operational excellence, and sustainability. Lear is Making every drive better by providing the technology for safer,...

  • IP Analyst II

    4 weeks ago


    Pune, Maharashtra, India Lear Corporation Full time

    Lear, a global automotive technology leader in Seating and E-Systems, enables superior in-vehicle experiences for consumers around the world. Our diverse team of talented employees in 38 countries is driven by a commitment to innovation, operational excellence, and sustainability. Lear is Making every drive better by providing the technology for safer,...

  • Associate Ii

    4 weeks ago


    Pune, Maharashtra, India TIAA Full time

    Sales Learning Development Manager The Sales Learning Development Manager contributes to the design delivery and administration of advisory services training programs in accordance with the organization s learning and development plan Under limited supervision this job works to meet the current and future human resource needs of the advisory services...