50 Regulatory Intelligence Jobs

1. Compilation / Review and submission of registration dossiers in Brazil, 2. Review and submission of responses to deficiencies received from regulated markets 3. Compilation / Review and submission of post-approval changes for regulated markets Location - R & D Center- Turkapally, Shameerpet, Hyderabad

Drug regulatory affairs (DRA) required at panipat for a MNC company Qualification- Any pharma Exp- min 2yrs in DRA salary- upto 45k Location- Panipat Wtsapp me resume at 8295842337- Mr. Bansal Required Candidate profile Prepare & submit regulatory dossiers, manage CTD/eCTD filings, coordinate with DCGI, handle queries & variations, ensure compliance, support audits, and maintain regulatory documentation.

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 protect the company's interests. Conducting regular legal audits and reviews of vendor and partner agreements to ensure adherence to terms and regulatory requirements will be part of your duties. In case of legal disputes, you will manage litigation processes and coordinate closely with external legal counsel when nec...

Role Overview: As a Manager in Business Regulatory Change Management Governance at American Express, you will play a crucial role in leading the end-to-end governance of regulatory change projects for AEBC. Your responsibilities will include setting the strategic direction, oversight, and execution of regulatory change, championing a culture of compliance, and ensuring alignment with the Bank's growth objectives. Your leadership, cross-functional collaboration, and ability to influence at all levels will be essential in delivering timely regulatory outcomes and supporting risk management within the business. Key Responsibilities: - Governance Leadership: Develop and implement structured gove...

About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. Job Description/ Capsule Collates information, communicates, and prepares responses for Health Authority queries to facilitate regulatory processes. Maintains and updates submission trackers to ensure accurate and up-to-date regulatory documentation. Supports the development of India-specific artwork, ensuring compliance with regulatory requirements. Supports the preparation and submissio...

As a Regulatory Affairs Manager, you will play a crucial role in developing and implementing global regulatory strategies to secure product approvals and market access in various regions such as FDA, EMA, MHRA, TGA, and Health Canada. Your responsibilities will include: - Serving as a CMC expert in managing Initial Submissions and Life cycle management activities for Global Regulatory across multiple markets and dosage forms including OSDs, Ophthalmic, Complex Injectable, and Liposomal Dosage forms. - Authoring high-quality CMC documentation such as Dossiers and Deficiency responses, ensuring technical congruency and regulatory compliance. - Leading cross-functional teams for new product dev...

About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. Job Description/ Capsule Collates information, communicates, and prepares responses for Health Authority queries to facilitate regulatory processes. Maintains and updates submission trackers to ensure accurate and up-to-date regulatory documentation. Supports the development of India-specific artwork, ensuring compliance with regulatory requirements. Supports the preparation and submissio...

As a Safety & PV Specialist I-Japanese at Syneos Health in Pune Office, your primary responsibility will be to ensure accurate and timely processing of Individual Case Safety Reports (ICSRs) in compliance with Standard Operating Procedures (SOPs) and regulatory requirements. You will play a crucial role in maintaining safety tracking, performing data entry into safety databases, coding events and medical history, and compiling narrative summaries. Additionally, you will be involved in the validation and submission of xEVMPD product records, management of duplicate ICSRs, and activities related to SPOR / IDMP. Key Responsibilities: - Ensure accurate and timely processing of Individual Case Sa...

Who We Are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. Th...

Dear Candidate, We are hiring for the Regulatory Affairs role-handling the below job responsibilities, Job Title: Regulatory Affairs Manager Company: Brinton Pharmaceuticals Ltd. Location: Kharadi, Pune Salary: Best in Industry Joining: Immediately Job Description: Regulatory Affairs Manager Position Overview: We are seeking an experienced and resourceful Regulatory Affairs Manager to lead efforts focused specifically on product approvals, price compliance, and regulatory risk mitigation in support of sales, pricing, and marketing. Key responsibilities include obtaining necessary approvals, ensuring price compliance, reviewing promotional materials, and addressing regulatory risks in domesti...

Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate; Competently writes regulatory and/or technical documents with minimal review by senior staff; Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues; Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance fro...

Job Summary: We are seeking a detail-oriented and proactive Executive Regulatory Affairs to ensure compliance with all regulatory requirements related to product registration, documentation, and approvals. The role involves preparing and submitting regulatory dossiers, maintaining product licenses, and liaising with authorities to support timely market access and product lifecycle management. The ideal candidate will have strong knowledge of regulatory guidelines, documentation practices, and submission processes applicable to [pharma / medical device / FMCG] industries. Key Responsibilities: Prepare, compile, and review regulatory documents and dossiers for submission to national and intern...

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...