2122 Regulatory Affairs Jobs - Page 32

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meanin...

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 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 Required Skills: Strong coping, emotional resilience, and ...

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Analyst Qualifications: BCom Years of Experience: 3 to 5 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 Help clients transform their compliance function from reactive to proactiv...

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: BCom Years of Experience: 0 to 1 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 Help clients transform their compliance function from reactive to pr...

Skill required: KYC Screening - Sanctions Screening Designation: Regulatory Compliance Analyst Qualifications: BCom Years of Experience: 3 to 5 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 Help clients transform their compliance function from reactive to proactive thr...

We are looking for a skilled Accounting Specialist to join our team in the Merchandise Payables department. The ideal candidate will have 6-10 years of experience in accounting and finance, with expertise in managing merchandise payables and ensuring timely payments. Roles and Responsibility Manage and process merchandise payables transactions accurately and efficiently. Coordinate with cross-functional teams to resolve payment-related issues and discrepancies. Develop and implement effective accounting procedures to improve financial performance. Analyze financial data to identify trends and areas for improvement in merchandise payables. Ensure compliance with company policies and regulator...

Mgr, RA EU Generics Labeling Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Area of Interest Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Mgr, RA EU Generics Labeling Jul 21, 2025 Bangalore, India, 560064 Who we are The opportunity Ensure the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products. Provide internal pharmaceutical and medical expertise to address internal and authority-related inquiries and resolve labeling issues. Ensure regulatory compliance for all ...

Job Title Senior Regulatory Affairs specialist Job Description Job title: Senior Regulatory Affairs Specialist Your role: Developing and executing the regulatory strategy for new product development, design changes and field safety corrections for US, EU, Canada and RoW. Participate in strategic product development, design solutions from the concept phase to the product delivery phase and provide regulatory guidance throughout design and development. Responsible for product registrations/approvals for their responsible products within IGT-S portfolio. Author and lead 510(k) submissions, pre-sub meetings, EU MDR Technical Documentation, and Health Canada license applications. Lead interaction...

1. Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other markets. 2. Support product development, registration, & lifecycle management in Europe 3. Manage Regulatory Compliance & Approvals Required Candidate profile 1. Minimum 10 years of experience in Formulations OSD 2. Willing to work in Chennai 3.Strong expertise in European, EMA, MHRA & other international regulatory framework 4.Knowledge of ICH & regulatory

As an Associate Regulatory Affairs, your primary role will be to assist in obtaining and maintaining regulatory approvals for beauty, health, wellness, cosmetics, and food products. It is crucial to achieve a balance between regulatory concerns, technology, marketing objectives, compliance, time to market, and costs. Your responsibilities will include preparing dossiers that are country and category-specific for domestic and international markets to ensure error-free and timely submissions according to department timelines. You will be responsible for coordinating with suppliers and vendors to maintain product master data. Additionally, you will review, prepare, submit, and coordinate with r...

As a Senior Regulatory Affairs Associate at our organization, you will play a crucial role in managing regulatory documentation, resolving technical queries from clients, and supporting vendor qualification processes. With a solid background in the Pharma raw material industry, particularly in excipient products, you will leverage your expertise to ensure compliance with regulatory standards and guidelines. Your responsibilities will include handling all regulatory documents related to excipients, addressing technical queries from pharmaceutical clients, managing technical matters and documentation for excipient manufacturers, and preparing technical documents for the promotion of excipient ...

Career Category Regulatory Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier li...

The MAC Reference Librarian will be responsible for managing the digital Reference Library and Match Text Library within the Veeva Global PromoMats system, while adhering to internal guidelines, SOPs (Standard Operating Procedures), policies and industry regulations. Roles & Responsibilities: Manage Reference and Match Text Libraries for multiple US MAC Teams Adding new Match Text records and adjusting existing records. Manage Amgen Label Reference documents in Veeva Organize annual reviews Supports Global Initiative/Other MAC related projects. Expert in MAC Reference Requirements and Veeva Reference & Annotation (R&A) technology. Performs Quality Check on all References uploaded into the Re...

The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketin...

Career Category Regulatory Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier ...

Career Category Regulatory Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas Oncology , Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier l...

Novo Medi Sciences seeks a Regulatory Affairs Manager with 10+ yrs exp. in ACTD/CTD dossiers for semi/non-regulated markets. Location: Dadar East, Mumbai. B Pharm/M Pharm. Must handle queries, submissions, product lifecycle, and lead a team

Career Category Regulatory Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier ...

Ignitho Technologies (India) Pvt Ltd is looking for Lead - Senior Associate to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports Processing requisition and other business forms, checking account balances, and approving purchases Advising other departments on best practices related to fiscal procedures Managing account records, issuing invoices, and handling payments Collaborating with internal departments to reconcile any accounting discrepancies Analyzing financial data and assisting with audits, reviews, and tax preparations Updating financial spreadsheets and reports with the latest availab...

Preparing, Reviewing and Submitting Product Dossiers as per Country Specific guidelines Preparing, Reviewing and Submitting Renewal Dossiers / Variations. Responding to queries raised by Regulatory authority of respective country. Preparing CAPA reports for the audit or market complaints. Coordinating with various department for Technical Documents as DMF, Stability data, FP COA, API COA, etc. Coordinating & Arranging for the registration samples as per country guideline. Reviewing & Approving the Artworks (Text Content) Coordinating with FDCA Person for COPP & GMP and its legalization process. Updating all registration status records. Maintaining Retain Samples Records. Coordinating with cu...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Gurgaon, Haryana, India Job Description: Required Qualification...

ROLES & RESPONSIBILITY Develop regulatory strategies for new/existing products. Ensure compliance with local/international regulations (CDSCO, ISO, FDA). Prepare and submit regulatory submissions. Monitor regulatory developments and adjust strategies. Liaise with regulatory bodies and internal teams for compliance. Conduct audits and maintain up-to-date knowledge of regulatory requirements. Required Qualifications: Bachelor s degree in a scientific discipline. 2 to 3 years experience in regulatory affairs within the medical device industry. In-depth knowledge of CDSCO, ISO, FDA standards. Experience with regulatory submissions and medical device development. Excellent communication, organiza...

Exp in regulatory affair policy analysis or compliance within power sector will be responsible for managing & ensuring compliance with all applicable law regulation policies & tariff orders governing solar wind & hybrid renewable energy projects Required Candidate profile In-depth knowledge of India's electricity laws, regulatory frameworks (Electricity Act, 2003), energy policies, and environmental regulations at both central and state (Karnataka is mandatory) levels

Roles and Responsibilities Should Have Formulation Experience. Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. Responding to queries with in the time lines receive...

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries....