38 Regulatory Intelligence Jobs

Job Description Job Responsibilities: International Registrations Upload, Verify, and Validate the data with new Regulatory Information to the RIM database Maintain Registration &Licensing Information Create Submission Packages for International Registrations Initiate Renewals with the countries. Initiate Product Change Notices per input from BU Project RA Specialist Establish and Maintenance of Dashboards on Product Change Notices Update PRAs (RIMSYS), NOR-D, and SAP system on regulatory status International and Local Labelling Initiate Local label Requests through Change Requests Monitor the status of the Label Change requests through Implementation Ensure timely completion of label releas...

Job Description Job Responsibilities: International Registrations Upload, Verify, and Validate the data with new Regulatory Information to the RIM database Maintain Registration &Licensing Information Create Submission Packages for International Registrations Initiate Renewals with the countries. Initiate Product Change Notices per input from BU Project RA Specialist Establish and Maintenance of Dashboards on Product Change Notices Update PRAs (RIMSYS), NOR-D, and SAP system on regulatory status International and Local Labelling Initiate Local label Requests through Change Requests Monitor the status of the Label Change requests through Implementation Ensure timely completion of label releas...

Job Description Job Responsibilities: International Registrations Upload, Verify, and Validate the data with new Regulatory Information to the RIM database Maintain Registration &Licensing Information Create Submission Packages for International Registrations Initiate Renewals with the countries. Initiate Product Change Notices per input from BU Project RA Specialist Establish and Maintenance of Dashboards on Product Change Notices Update PRAs (RIMSYS), NOR-D, and SAP system on regulatory status International and Local Labelling Initiate Local label Requests through Change Requests Monitor the status of the Label Change requests through Implementation Ensure timely completion of label releas...

Job Description Job Responsibilities: International Registrations Upload, Verify, and Validate the data with new Regulatory Information to the RIM database Maintain Registration &Licensing Information Create Submission Packages for International Registrations Initiate Renewals with the countries. Initiate Product Change Notices per input from BU Project RA Specialist Establish and Maintenance of Dashboards on Product Change Notices Update PRAs (RIMSYS), NOR-D, and SAP system on regulatory status International and Local Labelling Initiate Local label Requests through Change Requests Monitor the status of the Label Change requests through Implementation Ensure timely completion of label releas...

Job Description Job Responsibilities: International Registrations Upload, Verify, and Validate the data with new Regulatory Information to the RIM database Maintain Registration &Licensing Information Create Submission Packages for International Registrations Initiate Renewals with the countries. Initiate Product Change Notices per input from BU Project RA Specialist Establish and Maintenance of Dashboards on Product Change Notices Update PRAs (RIMSYS), NOR-D, and SAP system on regulatory status International and Local Labelling Initiate Local label Requests through Change Requests Monitor the status of the Label Change requests through Implementation Ensure timely completion of label releas...

Job Title Regulatory Affairs Operations Specialist Job Description Job Responsibilities: International Registrations Upload, Verify, and Validate the data with new Regulatory Information to the RIM database Maintain Registration &Licensing Information Create Submission Packages for International Registrations Initiate Renewals with the countries. Initiate Product Change Notices per input from BU Project RA Specialist Establish and Maintenance of Dashboards on Product Change Notices Update PRAs (RIMSYS), NOR-D, and SAP system on regulatory status International and Local Labelling Initiate Local label Requests through Change Requests Monitor the status of the Label Change requests through Impl...

Job Title Sr Regulatory Operation Specialist Job Description Job Responsibilities: International Registrations Upload, Verify, and Validate the data with new Regulatory Information to the RIM database Maintain Registration &Licensing Information Create Submission Packages for International Registrations Initiate Renewals with the countries. Initiate Product Change Notices per input from BU Project RA Specialist Establish and Maintenance of Dashboards on Product Change Notices Update PRAs (RIMSYS), NOR-D, and SAP system on regulatory status International and Local Labelling Initiate Local label Requests through Change Requests Monitor the status of the Label Change requests through Implementa...

Job Title Regulatory Affairs Operations Specialist Job Description Job Responsibilities: International Registrations Upload, Verify, and Validate the data with new Regulatory Information to the RIM database Maintain Registration &Licensing Information Create Submission Packages for International Registrations Initiate Renewals with the countries. Initiate Product Change Notices per input from BU Project RA Specialist Establish and Maintenance of Dashboards on Product Change Notices Update PRAs (RIMSYS), NOR-D, and SAP system on regulatory status International and Local Labelling Initiate Local label Requests through Change Requests Monitor the status of the Label Change requests through Impl...

Job Title Regulatory Affairs Operations Specialist Job Description Job Responsibilities: International Registrations Upload, Verify, and Validate the data with new Regulatory Information to the RIM database Maintain Registration &Licensing Information Create Submission Packages for International Registrations Initiate Renewals with the countries. Initiate Product Change Notices per input from BU Project RA Specialist Establish and Maintenance of Dashboards on Product Change Notices Update PRAs (RIMSYS), NOR-D, and SAP system on regulatory status International and Local Labelling Initiate Local label Requests through Change Requests Monitor the status of the Label Change requests through Impl...

Job Title Regulatory Affairs Operations Specialist Job Description Job Responsibilities: International Registrations Upload, Verify, and Validate the data with new Regulatory Information to the RIM database Maintain Registration &Licensing Information Create Submission Packages for International Registrations Initiate Renewals with the countries. Initiate Product Change Notices per input from BU Project RA Specialist Establish and Maintenance of Dashboards on Product Change Notices Update PRAs (RIMSYS), NOR-D, and SAP system on regulatory status International and Local Labelling Initiate Local label Requests through Change Requests Monitor the status of the Label Change requests through Impl...

Job Title Sr Regulatory Operation Specialist Job Description Job Responsibilities: International Registrations Upload, Verify, and Validate the data with new Regulatory Information to the RIM database Maintain Registration &Licensing Information Create Submission Packages for International Registrations Initiate Renewals with the countries. Initiate Product Change Notices per input from BU Project RA Specialist Establish and Maintenance of Dashboards on Product Change Notices Update PRAs (RIMSYS), NOR-D, and SAP system on regulatory status International and Local Labelling Initiate Local label Requests through Change Requests Monitor the status of the Label Change requests through Implementa...

Role Overview: You will be responsible for coordinating all transfer/transition related activities from sites/function to GQSI, monitoring service KPIs and process KQIs, and taking necessary actions to ensure service delivery targets are met. Additionally, you will be involved in recruiting, developing, managing, and appraising direct reporting associates, implementing succession planning, and mentoring for higher responsibilities. Ensuring efficient resource utilization, fostering innovation, and creating a multi-year GQS Roadmap with clear milestones will be key aspects of your role. You will also drive data-driven insights, partner with Digital/IT for transformation, and lead change manag...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical d...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical d...

HA (Health Authority) submissions and regulatory compliances for New Drugs, Line extension, additional indication, production transfer, site registration, renewal, CMC, PI, PSUR to ensure business continuity and support clinical trial projects under GDO and need-based support to other regulatory projects in CPO India To oversee and drive compliance activities within CPO and ensuring maintenance of the same as per stipulated timeline, About The Role Key Responsibilities Compilation and HA submissions of New Drug applications, Line extensions, additional indications along with the site registrations, renewals and production transfer applications for Novartis Pharma products and demonstrate ind...

Job Description The Asia Group is now accepting applications for an Associate Vice President to join our Mumbai office focusing on the financial services sector. The position will primarily support the firm's banking and financial sector clients while strengthening our regulatory intelligence capabilities in India's financial ecosystem. The Asia Group is a strategic and business advisory firm that supports Fortune 100 corporations with market entry and expansion strategies, stakeholder engagement strategies, and complex conflict resolution initiatives in the Indo-Pacific region. The Asia Group's clients cover a broad range of industries, including technology, manufacturing, energy, financial...

The Global Regulatory Policy & Intelligence (GRPI) group at Amgen engages with regulators, industry associations, and other stakeholders externally, and internally it manages regulatory intelligence for GRAAS monitoring, analyzing, and communicating regulatory requirements worldwide to enable fast, efficient global filings. The Senior Manager, as part of this team, plays a pivotal role in executing the regulatory intelligence function. Key Responsibilities: Regulatory Intelligence Deliverables: Contribute to the monitoring and analysis of the global regulatory landscape and develop agreed intelligence deliverables under the supervision of the Regulatory Intelligence Director. This includes p...

The Director leads the strategic development and execution of the Global Regulatory Intelligence (GRI) function, ensuring Amgen stays ahead of an evolving global regulatory landscape. This role defines the team's mission, sets priorities, leads cross-functional collaborations, and ensures high-impact intelligence is embedded into regulatory strategy across the enterprise. Key Responsibilities: Function Leadership & Vision: Establish and evolve the Regulatory Intelligence function, defining structure, staffing strategy, vendor/outsourcing model, and the technology roadmap to support global operations. Set the vision and oversee the execution of intelligence deliverables that enable accelerate...

The Manager in the Global Regulatory Intelligence team is a hands-on contributor responsible for gathering and organizing regulatory intelligence under the guidance of the RI Director. This role often has a technology and data focus , managing the tools and information that drive the intelligence process. Key Responsibilities: Intelligence Gathering & Analysis: Assist in monitoring and analyzing the global regulatory landscape, and in developing intelligence reports and updates as directed by the RI Director. A core duty is to collect and synthesize new or updated local regulatory requirements obtained from Amgens local regulatory teams, for the Managers assigned areas of responsibility. Thi...

Site Name: Warsaw, Bengaluru Luxor North Tower, Cairo Boomerang, Poznan Grunwaldzka Posted Date: Oct 1 2025 Are you looking for an opportunity to work on global projects and make a meaningful impact in the pharmaceutical industry Join the Delivery Team within SMMP as a Senior Regulatory Specialist and play a pivotal role in driving global Chemistry, Manufacturing, and Control (CMC) variation projects and Global Supply Chain (GSC) change programs for pharmaceutical products. As a Senior Regulatory Specialist, you will take on a key role in ensuring the timely and efficient delivery of regulatory activities across multiple CMC projects within the Pharma business. Your responsibilities will inc...

As a Legal Compliance Officer, your role involves ensuring strict and proactive compliance with all Reserve Bank of India (RBI) regulations, other applicable NBFC laws, and relevant financial services statutes. You will be responsible for drafting, reviewing, negotiating, and managing a wide range of legal agreements with customers, vendors, partners, and other third parties to safeguard the company's interests. Conducting regular legal audits and reviews of vendor and partner agreements will be a key part of your responsibilities to ensure adherence to terms and regulatory requirements. Your key responsibilities include: - Ensuring Regulatory Compliance: Adhering to all RBI regulations, NBF...

Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products Collaboration with partners to develop and execute global regulatory activities DMF preparations, review of changes and routine updates to Global Regulatory Agencies Dossier preparation...

Company Description Lawrbit Global Compliance Network is a provider of global compliance management solutions aimed at helping organizations proactively manage compliance risks through comprehensive regulatory intelligence covering 70+ countries and 1000+ regulatory bodies. Our in-house team of Lawyers and Company Secretaries collaborate with legal partners worldwide to offer a centralized framework for compliance control. With a focus on effective corporate governance and regulatory understanding, we enable businesses to confidently manage global regulatory compliance. Role Description This is a full-time on-site role for a Company Secretary at Lawrbit Global Compliance Network located in J...

What Will You Do: Assess regulatory intelligence for supporting development of local, regional, and global regulatory strategies. Evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle to ensure product compliance and anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions. Assist in the development of regulatory strategy and update strategy based upon regulatory changes. Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities. Provide regulatory information and guidance for product development and pla...

Job Description: Freyr is building a next-gen Regulatory Intelligence (RI) product powered by AI/ML and automation . We're looking for a Regulatory Intelligence Lead to drive high-quality data processes, manage RI surveillance, and lead a team working across global markets in Pharma, Medical Devices, and Consumer Products . Key Responsibilities: Manage RI data surveillance , quality checks , and regulatory insights across global markets Lead a team and ensure timely, accurate delivery of regulatory updates Resolve regulatory queries and support client-specific project needs Upload and manage data on digital platforms; suggest process improvements Maintain dashboards for real-time data tracki...