Senior Regulatory Affairs Associate- Labeling
1 week ago
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.-
Manager - Global Labelling Regulatory Affairs
2 weeks ago
Bengaluru, Karnataka, India Biocon Full timeBiocon Biologics is at the forefront of the healthcare industry revolution, placing patient needs above all else. Our goal is to positively impact the lives of billions by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. As a diverse global company, our employees are driven by purpose and passion to collaborate...
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Associate Regulatory Affairs Director I
1 week ago
Bengaluru, Karnataka, India AstraZeneca Full timeJob Title: Associate Regulatory Affairs Director I (International Regulatory Affairs) Career Level - E Introduction to Role: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and...
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Bengaluru, Karnataka, India Biocon Biologics Full timeBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where...
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Regulatory Affairs Manager I
1 week ago
Bengaluru, Karnataka, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to role: The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor, if required. The...
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Regulatory Affairs Manager I
2 weeks ago
Bengaluru, Karnataka, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to Role: Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a role that offers the opportunity to contribute to our drug development strategies and turn them into reality. As a regulatory specialist with project management capabilities, you will be responsible...
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Regulatory Affairs Associate I
1 week ago
Bengaluru, Karnataka, India AstraZeneca Full timeJob Title: Regulatory Affairs Associate ICareer Level - CIntroduction to Role:Join our International Regulatory Affairs Management (RAM) team as a Regulatory Affairs Associate I. This role offers an exciting opportunity to contribute to the development and approval of life-changing medicines for patients in international markets. As a Regulatory Affairs...
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Regulatory Affairs Manager I
1 week ago
Bengaluru, Karnataka, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...
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Regulatory Affairs Manager I
2 weeks ago
Bengaluru, Karnataka, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...
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Global Regulatory Affairs
1 week ago
Bengaluru, Karnataka, India Eli Lilly Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...
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Regulatory Affairs Associate I
1 week ago
Bengaluru, Karnataka, India AstraZeneca Full timeJob Title: Regulatory Affairs Associate I Career Level - C Introduction to Role: Join our Biopharmaceuticals R&D team as a Regulatory Affairs Associate I, where you will play a critical role in impacting patients in need. As a specialist, you will assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in...
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Regulatory Affairs Manager I
2 weeks ago
Bengaluru, Karnataka, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager ICareer Level - DIntroduction to Role:Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a regulatory specialist with project management capabilities. This role is responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. You will be expected to work...
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Regulatory Affairs Specialist
1 week ago
Bengaluru, Karnataka, India Biocon Full timeWe are hiring for dynamic individuals in Regulatory Affairs Department:Experience: 3 years up to 12 yearsDesignation: Senior Exec / Assistant Manager / Deputy ManagerQualification: M. Sc. / M. Pharma/ B.Pharma For Below Mentioned roles:Role 1: API Regulatory Affairs DMF filing / Submission. submission to global markets & handling health authority...
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Regulatory Affairs Manager I
1 week ago
Bengaluru, Karnataka, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to Role: Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a regulatory specialist with project management capabilities. This role is responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. You will be...
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Regulatory Affairs Specialist
1 week ago
Bengaluru, Karnataka, India Biocon Full timeWe are hiring for dynamic individuals in Regulatory Affairs Department: Experience: 3 years up to 12 years Designation: Senior Exec / Assistant Manager / Deputy Manager Qualification: M. Sc. / M. Pharma/ B.Pharma For Below Mentioned roles:Role 1: API Regulatory Affairs DMF filing / Submission. submission to global markets & handling health authority queries....
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Regulatory Affairs Operations Analyst
2 weeks ago
Bengaluru, Karnataka, India Lifelancer Full timeAbout the job Job Description Summary This position is responsible for the creation, identification, collection, and entry of regulatory affairs information of medical devices. Support related regulatory affairs activities, such as assessment, execution and management of regulatory data and information to support all regulatory needs and objectives of...
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Junior Regulatory Affairs Associate
4 weeks ago
Bengaluru, Karnataka, India Parexel Full timeKey Accountabilities:Project Administration:Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions.Provide basic regulatory...
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Junior Regulatory Affairs Associate
1 week ago
Bengaluru, Karnataka, India Parexel Full timeKey Accountabilities:Project Administration:Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions.Provide basic regulatory...
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Junior Regulatory Affairs Associate
4 weeks ago
Bengaluru, Karnataka, India Parexel Full timeKey Accountabilities:Project Administration:Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions.Provide basic regulatory...
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Senior Regulatory Professional
1 week ago
Bengaluru, Karnataka, India Novo Nordisk AS Full timeDepartment: Labelling Operations Are you a graphic designer who would like their work to impact patient's lives? Do you thrive in a working environment where close collaboration with key stakeholders and having and innovative mindset is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might...
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Regulatory Affairs Operations Analyst
1 week ago
Bengaluru, Karnataka, India Lifelancer Full timeAbout thejob Job DescriptionSummary This position isresponsible for the creation identification collection and entry ofregulatory affairs information of medical devices. Support relatedregulatory affairs activities such as assessment execution andmanagement of regulatory data and information to support allregulatory needs and objectives of the business....