Senior Drug Safety Regulatory Analyst

4 weeks ago

Bharatpur, Rajasthan, India InfoDesk Full time
About Infodesk www.infodesk.com Infodesk is the leading enterprise intelligence management Saa S platform, serving the top 100 companies across global life sciences, government, professional, and investment services.
Info Desk's proprietary "Smarter Data" technology gathers, normalizes, enriches, and summarizes content in real time from external and internal sources to deliver business-critical insights that help clients increase their competitive awareness, mitigate risks, and make confident data-driven strategic decisions.Info Desk is looking for a Senior Regulatory Delivery Analyst to provide and manage projects that meet the custom information needs of high-profile, clientele of global pharmaceutical and biotech companies.
This is a unique role and to be successful, you will have a deep understanding of regulatory submissions and requirements or product development, including research, clinical trials, manufacturing practices, regulations and approvals processes.Responsibilities: Ensure completion of regulatory projects for Info Desk's customers in line with customer scope Work directly with Info Desk internal stake holders establish and enforce scope of work and enable Info Desk's teams to fulfill services according to scopeResearch publicly available websites from Regulatory Authorities and other relevant websites to identify and manage the information strategy process.Create searches and apply standard "search logic" (including Boolean) to find certain websites that provide information on applicable laws and regulations.Evaluate applicable laws and regulations to determine impact on company and client activities Identify and interpret relevant regulatory guidelines, as they relate to Info Desk client projects Advise others on regulatory and compliance matters, as they relate to Info Desk client projects Explain regulations, policies, or procedures, as they relate to Infodesk stakeholdersCoordinate regulatory documentation activities, in accordance to client project scopesProvide technical review of data orreportsMaintain data in information systems or databasesAbility to navigate the Web and tools to consume content, like RSS, Google Alerts etc.Must have: BA/BS in scientific/engineering/healthcare discipline, Masters, Pharm D or Ph.
D preferred10-18 years in the Pharmaceutical Industry orregulatory strategy or similar training / experience Strong knowledge of current North America and EU regulations, and familiarity with internationalregulations.Knowledge of and broad experience with regulatory procedures and legislation for drug/device development (specifically Gx Ps), product registration, line extension and license maintenance (US, CA & EU required).
Understanding of regulatory controls and marketing pathways INDs/IDEs/BLAs/NDAs/510(k)s/PMAs, marketing applications and other regulatory submissions and pathways (orphan drug, PRIME, IRP etc)Ability to manage complex projects and timelines in a multinational/multicultural team environment

  • Senior Financial Regulatory Expert

    6 days ago

    Bharatpur, Rajasthan, India beBeeRiskManagement Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

    Financial Regulatory SpecialistWe are seeking a highly skilled professional to join our team as a Financial Regulatory Specialist.Job DescriptionThe successful candidate will be responsible for providing regulatory advisory services to clients, including:Leading advisory mandates involving regulatory interpretation and practical application, inspection...

  • Safety Operations Specialist

    19 hours ago

    Bharatpur, Rajasthan, India beBeeSustainability Full time ₹ 1,00,00,000 - ₹ 2,50,00,000

    Job Title:Marine & QSHE SuperintendentAbout the Role:This role is responsible for overseeing navigational and cargo practices, preparing for third-party inspections, and ensuring the implementation of our company's Safety Management System onboard.The successful candidate will have a strong understanding of SOLAS, MARPOL, STCW, ISM Code, ISO Standards, and...

  • Senior Food Regulatory Specialist

    4 days ago

    Bharatpur, Rajasthan, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000

    Job Opportunity:Senior Food Regulatory SpecialistThis role involves leading regulatory intelligence on domestic and international food labelling regulations across various markets.Responsibilities include monitoring, analysing and interpreting global regulatory updates and translating them into actionable implications for food businesses.A thorough...

  • Senior Credit Risk Analyst

    18 hours ago

    Bharatpur, Rajasthan, India beBeeCounterparty Full time ₹ 1,86,00,000 - ₹ 2,19,40,000

    Job Title: Senior Credit Risk Analyst Key Responsibilities:The Credit Risk Management team provides Counterparty Credit Risk management for financial institutions, proprietary trading groups, and CCPs. As a Senior Analyst, you will cover a portfolio of clients across one or several client types covered by the team.Main Accountabilities:

  • Senior Manager

    7 days ago

    Bharatpur, Rajasthan, India beBeeQuality Full time ₹ 15,00,000 - ₹ 25,00,000

    Job Title: Food Safety and Quality LeaderWe are seeking a seasoned Food Safety and Quality professional to lead our organization's food safety and quality efforts. This strategic role will oversee the development, implementation, and maintenance of our comprehensive food safety and quality management system.The ideal candidate will have a strong background...

  • Strategic Quantitative Analyst

    5 days ago

    Bharatpur, Rajasthan, India beBeeBiostatistician Full time ₹ 30,00,000 - ₹ 40,00,000

    Key Role: BiostatisticianThe Senior Biostatistician plays a pivotal position in our organization, responsible for leading and developing statistical strategies to support clinical trials.This individual will contribute to the planning, execution, and interpretation of statistical analyses across development programs. They must ensure high-quality, timely...

  • Senior Business Analyst

    2 days ago

    Bharatpur, Rajasthan, India beBeeBusiness Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Job Description">We enable financial institutions to drive digital transformation by delivering exceptional customer experiences across multiple channels.As a key member of our global team, you will work with top-tier clients on exciting projects that foster innovation and growth.About the Role">Lead the analysis and design of innovative solutions that meet...

  • Regulatory Compliance Specialist

    6 days ago

    Bharatpur, Rajasthan, India beBeeRegulatory Full time ₹ 17,59,300 - ₹ 23,99,130

    Compliance Professional RoleWe are seeking a highly skilled and experienced Compliance Professional to join our team.Job Summary:The Compliance Officer will be responsible for ensuring adherence to regulatory requirements, providing compliance guidance, and continuously tracking and evaluating regulatory updates relevant to the organization.Key...

  • Senior Quantitative Risk Analyst

    6 days ago

    Bharatpur, Rajasthan, India beBeeRiskModeller Full time ₹ 1,00,00,000 - ₹ 2,00,00,000

    Job Title: Lead Risk Modelling AnalystAbout the PositionWe seek a highly analytical and experienced Lead Risk Modelling Analyst to join our credit rating team. This role involves building, validating, and refining quantitative models that support credit rating decisions, risk assessments, and financial forecasts.Key ResponsibilitiesModel Development &...

  • Market Insights Analyst

    7 days ago

    Bharatpur, Rajasthan, India beBeeResearch Full time ₹ 10,00,000 - ₹ 15,00,000

    Job Title: Market Insights AnalystJob Description:We are seeking an experienced Research Analyst to join our team. The ideal candidate will have 1-2 years of experience in the Cement, Infrastructure, and Real Estate sectors. The successful applicant will be responsible for conducting in-depth industry research, financial analysis, and assisting senior...