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Regulatory Affairs Specialist-API
3 days ago
DMF compilation and submission to global markets
Handling post approval submission and CIP assessments
Submission of DMF amendment & response to Health Authority queries
Providing customer support
Evaluating change control assessment
Providing Regulatory input for New molecule development activities
Maintaining Regulatory data base
Qualification: M.Sc./ M. Pharm
Exp: 10years - 15years
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Regulatory Affairs Manager II
4 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager II (International Regulatory Affairs) Career Level - D 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 business to...
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Regulatory Affairs
2 weeks ago
Bengaluru / Bangalore, Chennai, India Ajay Bhardwaj (Proprietor Of Ocean Biomed) Full timeSummary:The Regulatory Affairs Officer ensures that pharmaceutical products comply with industry regulations. This role involves preparing and submitting regulatory documents, managing compliance, and maintaining product approvals.Roles and Responsibilities:Regulatory Submissions: Prepare and submit regulatory documents for product approvals and...
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Regulatory Affairs Manager I
2 weeks ago
Bangalore, 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 expected...
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Regulatory Affairs Associate I
4 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Associate I Career Level - C Introduction to Role: Join our International Regulatory Affairs Management (RAM) team as a Regulatory Affairs Associate I. This role is an exciting opportunity to contribute to the development and approval of life-changing medicines for patients in international markets. As a Regulatory...
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Regulatory Affairs Manager II
4 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager II Career Level - D Introduction to Role: Join our International Regulatory Affairs team at AstraZeneca, where we are committed to bringing life-changing medicines to patients in international markets as efficiently and effectively as possible. We have an exciting opportunity for a Regulatory Affairs Manager...
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Regulatory Affairs Manager I
4 weeks ago
Bangalore, 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
4 weeks ago
bangalore, 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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Specialist- Regulatory Affairs
2 days ago
bangalore, India Baxter Full timeThis is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found...
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Regulatory Affairs Manager I
1 week ago
bangalore, 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
1 week ago
Bangalore, 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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iCMC Regulatory Affairs Manager
3 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: iCMC Regulatory Affairs Manager Career Level - D Introduction to Role: Join our Biopharmaceuticals R&D team as an iCMC Regulatory Affairs Manager. This is an exciting opportunity to innovate in a safe environment, where you will be part of a team with deep specialist knowledge and regulatory expertise. We are confident in what we know...
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Regulatory Affairs Manager I
3 weeks ago
bangalore, 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...
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Regulatory Affairs Manager I
4 weeks ago
Bangalore, 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
2 weeks ago
Bangalore, 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 Specialist
1 month ago
bangalore, India Novo Nordisk AS Full timeDepartment : RA Labelling Are you passionate about ensuring regulatory compliance and driving high-quality global packaging materials? Do you have expertise in labelling and project management? We are looking for a Regulatory Specialist to join our team in Bangalore and be part of our global Regulatory Affairs (RA) hub. If you are ready for a...
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Regulatory Affairs Manager I
4 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to Role: Join our dynamic International Regulatory Affairs team at AstraZeneca, where we are committed to bringing life-changing medicines to patients across the globe. We have an exciting opportunity for a Regulatory Affairs Manager I to contribute to our mission. In this role,...
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Regulatory Affairs Specialist-API
3 days ago
bangalore, India Biocon Full timeRole Summary /Key Responsibilities DMF compilation and submission to global markets Handling post approval submission and CIP assessments Submission of DMF amendment & response to Health Authority queries Providing customer support Evaluating change control assessment Providing Regulatory input for New molecule development activities Maintaining...
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Regulatory Affairs Manager I/II
2 days ago
bangalore, India AstraZeneca Full timeJOB TITLE: Regulatory Affairs Manager I/II CAREER LEVEL: D Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in...
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Regulatory Affairs Manager I/II
4 days ago
Bangalore, India AstraZeneca Full timeJOB TITLE: Regulatory Affairs Manager I/II CAREER LEVEL: D Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping...
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Lead - Regulatory Affairs
1 month ago
bangalore, India Indegene Full timeTitle: Lead - Regulatory Affairs Date: May 10, 2024 Location: Bangalore, KA, IN We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain...