2122 Regulatory Affairs Jobs - Page 31

Educational Requirements Bachelor of Engineering Service Line Infosys Quality Engineering Responsibilities Global Pay Plus Testers. MT MX messaging , SWIFT payments Preferred Skills: Banking-GPP Financial Services Domain-Payments-GPP Generic Skills: Banking

Role & responsibilities Asst. Manager (Regulatory Affairs) 1. The Candidate must be M.Sc or B.Pharma or M.Pharma with 7-12 years of experience out of which minimum 3-4 years in regulatory affairs in EU, US markets, WHO GMP certified pharmaceutical formulation company. He will be responsible for all regulatory functions- domestic as well as exports. He will coordinate with other departments on regular basis. He will provide documentation support required for regulatory submission independently, including preparation and submission of dossiers for product and plant registrations in different countries as per latest guidelines. Exposure to Regulatory Audits & QMS system. Knowledge of Drug & Cos...

Role : Senior Executive Qualification: M. Pharma/B. Pharma Experience : 4 to 8 Years Location : Dholka, Gujarat Responsibilities 1. Preparation and submission of registration and re-registration dossiers as per country requirements of ROW (Preferable Russia, CIS countries and WHO) 2. Arrangement for indent of Samples, Packing Material specimen, Impurities, Reference Standards as per submission requirement. 3. Query evaluation and submission with respective countries requirement within the required time frame. 4. Establish coordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within time frame. 5. Post approval activities: Subm...

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

We are currently hiring for DSA I role with a minimum of 1 year experience in Pharmacovigilance Perform triage & intake of ICSR received daily in ARGUS databases. Ensure data entry of ICSR in ARGUS Required Candidate profile A minimum of 1 year pharmacovigilance case processing experience. Responsible for coding events using MEDDRA Any Life Sciences(B pharm/M Pharm/ Pharm D, Life Sciences, Nursing, BDS, BPT) are Eligible

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Job description Should have knowledge in clinical research studies Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) should have knowledge in ICH GCP Guidelines Required Candidate profile Minimum Bachelor's or Masters degree in related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Are Applicable to Apply

Role & responsibilities Job Title: International Regulatory Affairs (IRA) Sr. Manager Location: Ahmedabad -HO Markets: CIS (Including EAEU), LATAM (Central and South America), Middle East, Africa, South East Asia. Key Responsibilities: 1.Prepare monthly regulatory MIS reports and present status updates, key metrics, and strategic insights to senior management. 2. Manage relationships with external regulatory consultants, in-country partners, submission vendors, and the external regulatory team to ensure timely regulatory filings and ongoing compliance. 3. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap ...

1.To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all Latam and CIS , ROW Countries and other country as per company requirements. 2.Responsible for final review of dossier before submission. 3.To coordinate with technical team for documents required for dossier. 4.Responsible to gather data related for dossier through online sources, laboratories, manufactures etc. 5.Reviewing artwork for products as per relevant regulatory authority requirements. 6.To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the re...

Dear All, We are looking candidates for our R&D Centre in Drug Regulatory Affairs for Europe market. Company Name : V-Ensure Pharma Technologies Pvt. Ltd Location : Koparkhairane Role & responsibilities 1. Head and mange EU including UK regulatory team 2. Handle & lead the team for successful approval. 3. Define regulatory strategy for EU filings 4. Preparation of regulatory strategy & checklist as per country specific requirements. 5. Coordinating with cross functional departments ADL/FRD/QA/AL to procure the documents for review and compilation. 6. Coordinating with BD/Client/Vendor as per documents requirement. 7. Reviewing all CMC documents for adequacy and accuracy before compilation/ s...

As an experienced professional in the pharmaceutical industry, you will be responsible for ensuring the pharmaceutical, medical, and regulatory accuracy of English product information for European procedures. In this role, you will work with innovative, biosimilar, and generic products, contributing to regulatory compliance and addressing internal and authority-related inquiries. Your day-to-day activities will involve creating and updating compliant English product information for EU procedures, strategic planning for changes affecting multiple product documents, evaluating and approving change requests, and coordinating submissions with EU regulatory units. Additionally, you will collabora...

As a Manager of Operations at ZOLL, you will play a crucial role in organizing and overseeing the daily operations of our company. Your primary responsibility will be to ensure that our business functions smoothly and efficiently by managing procedures and guiding our team members. Your role will encompass a wide range of operational tasks, necessitating a deep understanding of various company processes. We are seeking a competent individual who can effectively plan and execute diverse operational activities, demonstrating strong leadership qualities to optimize the business operations. Your goal will be to enhance the efficiency of our operations, fostering growth and long-term success. Key...

Responsibilities: * Collaborate with cross-functional teams on product development and launch. * Ensure compliance with regulatory requirements throughout lifecycle. * Manage medical device submissions and recalls. Annual bonus Over time allowance Travel allowance

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to customers across different geographies. The business is structured into two main segments: Specialty Pharmaceuticals and Generics & APIs. Specialty Pharmaceuticals includes Radiopharmaceuticals, Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products. Generics & APIs include Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly-owned subsidiary of Jubilant Pharma with Research & Development units in Noida and Mysore, India. The company operates manufacturing facilities in Mysore, Karnataka, and Roorke...

: Prepare and maintain the Signal Schedule as per Standard Operating Procedures. Identification, Analysis, and Evaluation of safety signals arising from various data sources to determine signals or risks that could result in changes to labels and / or benefit-risk profile of the product. Evaluate the safety information and prepare product specific ADR (Adverse Drug Reaction) Sheet. Author Drug Safety Report (DSR) for Valid signals as per Standard Operating Procedures. Communicate findings from routine and ad hoc signal detection and assessment activities to concerned stakeholders. Contribute to cross-functional initiatives aimed at improving pharmacovigilance capabilities related to signal d...

We are looking for a highly skilled and experienced Legal Receivable Officer to join our team at Equitas Small Finance Bank. The ideal candidate will have 14 years of experience in the BFSI industry, with expertise in legal receivables. Roles and Responsibility Manage and oversee the collection process of outstanding debts from customers. Develop and implement effective strategies to minimize bad debt and improve cash flow. Collaborate with internal teams to resolve customer disputes and payment issues. Analyze and report on delinquency trends and provide insights for improvement. Ensure compliance with regulatory requirements and company policies. Maintain accurate records and reports of al...

We are looking for a highly skilled and experienced Receivable Officer to join our team at Equitas Small Finance Bank. The ideal candidate will have 1-4 years of experience in the BFSI industry, preferably with a background in receivables. Roles and Responsibility Manage and oversee the collection process to ensure timely recovery of outstanding amounts. Develop and implement effective strategies to minimize bad debt and improve cash flow. Collaborate with internal teams to resolve customer complaints and disputes. Analyze financial data to identify trends and areas for improvement in the receivable process. Ensure compliance with regulatory requirements and company policies. Maintain accura...

We are looking for a skilled Technical Manager with 4 to 7 years of experience to join our team at Equitas Small Finance Bank in the BFSI industry. Roles and Responsibility Manage and oversee technical projects from initiation to delivery, ensuring timely completion and quality results. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and implement technical solutions to meet business needs, leveraging expertise in BFSI technologies. Provide technical guidance and support to junior team members, promoting knowledge sharing and skill development. Analyze project performance data to inform decision-making and optimize processes. Ensure compliance...

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 Apex Group was established in Bermuda in 2003 and is now one of the worlds largest fund administration and middle office solutions providers. Our business is unique in its ability to reach globally, service locally and provide cross-jurisdictional services. With our clients at the heart of everything we do, our hard-working team has successfully delivered on an unprecedented growth and transformation journey, and we are now represented by over circa 13,000 employees across 112 offices worldwide.Your career with us should reflect your energy and passion. Thats why, at Apex Group, we will do more than simply empower you. We will work to supercharge your unique skills and experience. Take t...

Education Qualification - Pursuing or completed BSc or MSc in Microbiology, Life Sciences, or Biotechnology What We Want You To Do Execute required activities as part of ISO 13485 and ISO 15189 compliance Undertake activities as part of manufacturing documentation under ISO 13485 Undertake activities in molecular kit development and kit packaging departments Preparation of regulatory document dossier Requirements The candidate must have the ability to execute tasks and document information independently. Have a basic understanding of quality assurance and quality checks Awareness of ISO 13485 and ISO 15189 Skills Keen attention to details. Ability to critically evaluate scientific literature...

Company Name: Exemed Pharmaceuticals Designation - Drug Regulatory Affairs -Officer/Sr Officer Location - Vadodara ( Corporate Office) Market: Domestic Primary Job Descriptions Having knowledge of SUGAM portal and CDSCO website Submission for Mfg. & Mkt. Applications [CT21/CT-18] for IND, New Drug, Subsequent New Drug, FDC. Application of CT-05 / CT- 04 Application of CT-10 / 12/ 13 Application of import Licenses [CT-16/ Form 12/Form 08] Knowledge of IPC submissions Form 29 application Preparation of presentation for Subject Expert committee (SEC) Product Lifecycle & Management Additionally, should be well verse with Preparation of Module 4 & 5 Nonclinical & Clinical data Preparation of Pack...

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP HCM Payroll Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in problem-solving activi...

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Scienc...