Reg. Affairs Officer

3 weeks ago


Bengaluru, India IQVIA Full time

Job Description
- Data Management: Ensuring accurate and up-to-date product information is entered into the xEVMPD database, including details such as product name, active substances, dosage forms, indications, and packaging information.
- Database Administration: Overseeing the management and administration of the xEVMPD database, including user access control, data validation, and system maintenance.
- Regulatory Compliance: Ensuring compliance with EU regulations and guidelines for the electronic submission of product information to regulatory authorities, including timely and accurate updates to the xEVMPD database.
- Collaboration and Communication: Coordinating with internal stakeholders, such as regulatory affairs, pharmacovigilance, and quality teams, to gather and verify product information. Collaborating with external partners, such as marketing authorization holders, to obtain necessary data for submission.
- Data Quality Assurance: Conducting data quality checks and audits to ensure the integrity and accuracy of product information within the xEVMPD database. Resolving any discrepancies or errors identified during the validation process.
- Reporting and Documentation: Generating reports and preparing documentation related to xEVMPD submissions, data updates, and compliance activities. Maintaining records of submissions and ensuring proper documentation of changes and updates.
- Training and Support: Providing training and support to internal stakeholders on xEVMPD requirements, data entry processes, and system usage. Assisting users in troubleshooting issues related to data entry or database functionality.
- Stay Updated with Regulations: Keeping abreast of changes and updates in EU regulatory requirements for xEVMPD and ensuring compliance with evolving guidelines and regulations.
- Process Improvement: Identifying opportunities for process optimization and streamlining data management workflows related to xEVMPD submissions. Implementing improvements to enhance efficiency and data accuracy.



  • Bengaluru, India Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Purpose Organization Background Our Medical Affairs Quality Content Review Group is dedicated to ensuring the highest standards of medical quality, accuracy, and compliance across all our endeavors, ensuring our customers receive accurate and timely...


  • Bengaluru, India Eli Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...


  • Bengaluru, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...


  • Bengaluru, India ResMed Full time

    Summary: A Regulatory Affairs Administrative Assistant provides essential support to regulatory affairs professionals in managing compliance, documentation, and administrative processes. They play a crucial role in ensuring smooth operations within the regulatory department. Responsibilities and Accountabilities: Document Management: Assist in...


  • Bengaluru, India Baxter Full time

    Vantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...

  • Equities Coo Function

    4 weeks ago


    Bengaluru, India HSBC Full time

    **Business: Markets** **Open Positions:01** **Role Title: Equities COO Function - Markets Front Office, Bangalore Global Career Band: 5** **Location: Bangalore, India** Job Purpose: HSBC's Global Markets business is one of the largest of its kind in the world. It combines sophisticated 24-hour global coverage with a detailed knowledge of local markets....


  • Bengaluru, India Indegene Full time

    Title: Lead - Regulatory Affairs Date: May 10, 2024 Location: Bangalore, KA, IN We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a...


  • Bengaluru, Karnataka, India Australian Government Full time

    Non-ongoing, Fixed Term Contract - INR56,921 per month - Bengaluru, India **About the Department of Foreign Affairs and Trade (DFAT)** The role of the Department of Foreign Affairs and Trade (DFAT) is to advance the interests of Australia and Australians internationally. This involves strengthening Australia’s security, enhancing Australia’s...


  • Bengaluru, India Novo Nordisk Full time

    Regulatory Professional I **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department: Global Regulatory Affairs**Position**- Furthermore, in the role you will also handle: - Compile, review and submit pre-meeting packages for authority meetings. - Handle change requests. - Submission of regulatory files, response to...


  • Bengaluru, India Biocon Biologics Full time

    Manager – Global Regulatory AffairsLocation – Head-Office, Bangalore, INBIOCON BIOLOGICSBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation,...


  • Bengaluru, India Biocon Biologics Full time

    Manager – Global Regulatory AffairsLocation – Head-Office, Bangalore, INBIOCON BIOLOGICSBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation,...


  • Bengaluru, India Biocon Biologics Full time

    Manager – Global Regulatory AffairsLocation – Head-Office, Bangalore, INBIOCON BIOLOGICSBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation,...


  • Bengaluru, India Biocon Full time

    Manager - Global Regulatory Affairs. Location - Head-Office, Bangalore, IN. BIOCON BIOLOGICS. Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable...


  • Bengaluru, India Novo Nordisk Full time

    Regulatory Professional **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department: Global Regulatory Affairs** - Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment?...

  • Credit Middle Office

    4 weeks ago


    Bengaluru, India JPMorgan Chase Bank, N.A. Full time

    In this role, you will primarily support the JPMorgan Wealth Management Domestic credit business. You will work directly with Lending Specialists, Analysts, Underwriters and Credit Officers throughout the credit approval process. Your primary responsibilities and functions are as follows: - Partner with Underwriters and Lending Specialists to capture terms...


  • Banaswadi, Bengaluru, Karnataka, India COEQUAL SERVICES Full time

    **ONLY FEMALE CANDIDATE IS PREFERRED** **THIS LEGAL ADVISOR CORPORATE AFFAIRS JOB IS FOR WORK FROM OFFICE** **We are recruiting for our company** **OFFICE ADDRESS**: **COEQUAL SERVICES** 101, Sarovar Mansion, 'A' Block, First Floor, Dodda Banaswadi Main Rd, Annaiah Reddy Layout, Banaswadi, Bengaluru, Karnataka 560 043. LANDMARK: OPP TO KUNDAN...


  • Bengaluru, India Empower Full time

    **Grow your career with a growing organization** Whether they’re helping people reach their long-term financial goals or providing personal wealth management strategies, every associate contributes to changing the lives of those we serve for the better. When it comes to job satisfaction, that’s hard to beat. And from a personal satisfaction perspective,...


  • Bengaluru, Karnataka, India Novo Nordisk Full time

    Regulatory Professional I - Labelling **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN- .**Department**:RA Labelling Projects & Planning- **The position** - As a Regulatory Professional I - Labelling at Novo Nordisk, you will be responsible for the following: - Packaging Material Coordination: Collaborate with...


  • Bengaluru, Karnataka, India Novo Nordisk Full time

    Regulatory Professional I - Clinical trial Submission **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**:EU Submissions Hub- Are you ready to make a difference in the lives of millions of people living with a serious chronic disease? Join Novo Nordisk, a proud life-science company on a mission to ensure...

  • Equities Coo Function

    1 month ago


    Bengaluru, Karnataka, India HSBC Full time

    -Job description **Some careers shine brighter than others.** If you’re looking for a career that will help you stand out, join HSBC and fulfil your potential. Whether you want a career that could take you to the top, or simply take you in an exciting new direction, HSBC offers opportunities, support and rewards that will take you further. HSBC is one...