38 Regulatory Intelligence Jobs - Page 2

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...

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 Labeling Specialist responsible for Pre-evaluation of Reference Country Strategies, Deviation creation, Pre-evaluation of DLs, CCDS Update process till Global Dispatch, Binder creation, Attending Product PET meetings, Literature search , GLS QA check for Labeling Deviations Dashboard, Internal GLM meetings,...

Role Overview: 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 Ind...

As a Safety & Pharmacovigilance Specialist I at Syneos Health, you will play a crucial role in ensuring the safety and well-being of patients participating in clinical trials and post-marketing programs. Your responsibilities will include entering information into PVG quality and tracking systems, preparing project plans, processing ICSRs according to SOPs, and generating accurate reporting of expedited reports in compliance with regulatory requirements. You will be responsible for triaging ICSRs, evaluating data completeness and accuracy, entering data into safety databases, compiling narrative summaries, and assessing information to be queried. Additionally, you will participate in activit...

As a Legal Compliance Specialist, your primary responsibility will be to ensure 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 will also be a key aspect of your role to ensure adherence to terms and regulatory requirements. In addition, you will be tasked with effectively managing legal disputes, overseeing litiga...

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...

As a Regulatory Compliance Specialist, your primary responsibility will be to ensure that company products adhere to relevant regulatory requirements, including those stipulated by USFDA, FDA, EMA, and local regulatory bodies. You will be tasked with preparing and submitting regulatory documents such as INDs, NDAs, and MAAs to regulatory agencies. Additionally, you will play a pivotal role in developing and executing regulatory strategies that support product development and commercialization efforts. Your role will also involve staying abreast of evolving regulatory standards and providing guidance to internal stakeholders based on regulatory intelligence. You will coordinate and oversee re...

As the Director of Regulatory Research & Intelligence at Kamet Consulting Group, you will be responsible for leading and developing a team of research consultants in the life sciences and healthcare technology industry. Your role will involve overseeing regulatory intelligence, compliance support, and advisory services for clients in the pharmaceutical and medical device sectors. You will be the key authority for regulatory research activities in India, ensuring delivery excellence, quality control, and strategic insights. Your core responsibilities will include building and mentoring a team of research consultants, setting performance targets, and fostering their professional development. Y...

JD for Regulatory Affairs Executive We have requirement who have experience in AERB CDSCO BIS Plastic Waste ISO Share your cv - rekha@mi.konicaminolta.in

The candidate will be responsible for researching, analysing, and summarizing complex regulatory information, translating it into insightful and compliant reports. You will research and monitor regulatory requirements, guidelines, and industry trends from agency websites. Additionally, you will analyse and interpret regulatory information, provide concise and accurate summaries, and prepare high-quality regulatory intelligence. It is important to maintain up-to-date knowledge of global regulations and standards, contribute to regulatory strategies, and ensure timely delivery of reports. Qualifications for this role include a BSc/B. Pharm in a related field such as Life Sciences, Pharmacy, Re...

Assists in the maintenance of registrations and licenses of the products in RA systems and database such as SharePoint and other team folders as necessary. Performs labelling reviews and assisting in project creation in the Artwork Management system (WebCenter) as needed. Ensures timely submission of in renewal, site registrations and minor product submissions to relevant Health Authorities in APAC countries. Ensures effective communication across RA (top-down and botom-up) Ensures timely Veeva Vault update related to LCM activities such as MA renewal, site registration, and other minor product submissions as needed. Supports in the request of samples collection via K2 system. Generates regi...

Job Summary The TM-Pharmacovigilance role involves ensuring the safety and efficacy of pharmaceutical products through vigilant monitoring and analysis. With a focus on regulatory intelligence the candidate will contribute to maintaining compliance and enhancing customer service. This hybrid role requires rotational shifts and proficiency in English with no travel obligations. Responsibilities Monitor and analyze adverse drug reactions to ensure patient safety and product efficacy. Collaborate with cross-functional teams to gather and interpret regulatory intelligence data. Provide expert guidance on pharmacovigilance processes to enhance customer service experiences. Develop and implement s...