Senior Regulatory Affairs Associate- Labeling

1 week ago


mumbai, India Parexel Full time

When our values align, there's no limit to what we can achieve.
 

Regulatory Affairs Labeling

Must have 4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging) The ability to research and create comparator labeling documents. Strong understanding and experience creating annual reports. The ability to collaborate with Tech Ops for artwork implementation. Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system. Electronic document management systems use and / or electronic submission experience. Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.

  • Navi Mumbai, Maharashtra, India Teva Pharmaceuticals Full time

    The opportunity The RA Associate II, under direct supervision, is responsible for the preparation of high-quality US Gx labeling documents filed under an ANDA while ensuring adherence to federal regulations and meeting deadlines driven by company goals. Candidate should possess a knowledge of FDA US labeling regulations and guidance's to the level of...


  • Mumbai, Maharashtra, India Fusion Market Research Full time

    Regulatory affairs officers ensure that products such as foods, cosmetics, pharmaceuticals and veterinary medicines - and the steps involved in developing, testing and marketing them - meet legislative requirements. **Typical duties include**: - studying scientific and legal documents to check they meet legal requirements. - gathering, evaluating,...


  • Mumbai, India Apotex Full time

    About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...


  • Navi Mumbai, India Teva Pharmaceuticals Full time

    The opportunityThe RA Associate II, under direct supervision, is responsible for the preparation of high-quality US Gx labeling documents filed under an ANDA while ensuring adherence to federal regulations and meeting deadlines driven by company goals. Candidate should possess a knowledge of FDA US labeling regulations and guidance's to the level of applying...


  • navi mumbai, India Teva Pharmaceuticals Full time

    The opportunity The RA Associate II, under direct supervision, is responsible for the preparation of high-quality US Gx labeling documents filed under an ANDA while ensuring adherence to federal regulations and meeting deadlines driven by company goals. Candidate should possess a knowledge of FDA US labeling regulations and guidance's to the level of...


  • navi mumbai, India Teva Pharmaceuticals Full time

    The opportunity The RA Associate II, under direct supervision, is responsible for the preparation of high-quality US Gx labeling documents filed under an ANDA while ensuring adherence to federal regulations and meeting deadlines driven by company goals. Candidate should possess a knowledge of FDA US labeling regulations and guidance's to the level of...


  • Navi Mumbai, India Teva Pharmaceuticals Full time

    The opportunityThe RA Associate II, under direct supervision, is responsible for the preparation of high-quality US Gx labeling documents filed under an ANDA while ensuring adherence to federal regulations and meeting deadlines driven by company goals. Candidate should possess a knowledge of FDA US labeling regulations and guidance's to the level of applying...


  • Mumbai, Maharashtra, India Apotex Research Private Limited Full time

    **About Apotex Inc.** Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...


  • Navi Mumbai, India Teva Pharmaceuticals Full time

    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...


  • Navi Mumbai, India Teva Pharmaceuticals Full time

    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...


  • Mumbai, India RIGHT STAFF Full time

    Greetings from Right Staff One of our client who are into Medical Devices Are looking for a Regulatory Affairs person at Delhi NCR Job Description - Designation - Regulatory Affairs/QA Affairs Time - Day Shift Location - Delhi NCR **Responsibilities**: - 1. Identify regulatory and post market requirements for new products or product enhancements early...


  • Mumbai, India Abbott Full time

    CORE JOB RESPONSIBILITIES Primary Function/Primary Goals/Objectives : Combine knowledge of scientific, regulatory, and business issues to enable Abbott Nutrition products/business activities to meet required legislation. Develop and supervise regulatory professionals.  Have department level influence and be generally recognized as an expert...


  • Mumbai, Maharashtra, India Abbott Full time

    CORE JOB RESPONSIBILITIES Primary Function/Primary Goals/Objectives : Combine knowledge of scientific, regulatory, and business issues to enable Abbott Nutrition products/business activities to meet required legislation. Develop and supervise regulatory professionals. Have department level influence and be generally recognized as an expert...


  • mumbai, India Abbott Full time

    CORE JOB RESPONSIBILITIES Primary Function/Primary Goals/Objectives : Combine knowledge of scientific, regulatory, and business issues to enable Abbott Nutrition products/business activities to meet required legislation. Develop and supervise regulatory professionals.  Have department level influence and be generally recognized as an...


  • Andheri East, Mumbai, Maharashtra, India Career Strategy Solutions Full time

    Seeking Drug Regulatory Affairs for a Company into Pharma Industry **Key Responsibilities**: - Research and stay updated on regulatory requirements and guidelines - Coordinate with cross-functional teams to gather necessary documentation and information for regulatory filings - Review and assess product labeling, packaging, and promotional materials to...


  • Mumbai, India Apotex Full time

    About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...


  • mumbai, India Apotex Full time

    About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...


  • mumbai, India Apotex Full time

    About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...


  • Mumbai, India Apotex Full time

    About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...


  • Mumbai, India Colgate-Palmolive Full time

    Relocation Assistance Offered Within Country 156756 - Mumbai, Maharashtra, India **Who We Are** Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries...