Formulation Regulatory Affairs Specialist
3 days ago
- Preparation, review, and timely submission of ANDA in US market.- Deficiency and life cycle management for the products filed in US.- Review of technical (developmental and plant) documentations required for dossier submission.- Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during different stages of product development and manufacturing.- Publishing the necessary regulatory dossiers into eCTD format as per the country requirement.- Maintaining the necessary regulatory databases concurrently as on when regulatory updates are received.- Responsible to understand the requirements related to US regulatory submissions.
Qualification: M.Pharm/B.Pharm
Experience: 8 Years to 12 Years
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Regulatory Affairs Specialist
2 weeks 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 Specialist
2 weeks 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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Formulation Regulatory Affairs
10 hours ago
Bengaluru, India Biocon Full timeRole -Formulation Regulatory Affairs Role - US / Canada MarketLevel - Associate Manager / Manager - US MarketRequired Education/Exp:Experience Req.: 11 - 16 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and knowledge on life cycle...
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Formulation Regulatory Affairs
13 hours ago
Bengaluru, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada Market Level - Associate Manager / Manager - US Market Required Education/Exp: Experience Req.: 11 - 16 yrs. Qualification: - M.Sc. / M. Pharma. Responsibilities Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules. Experience and knowledge on...
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Formulation Regulatory Affairs
2 days ago
Bengaluru, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Associate Manager / Manager - US Market Required Education/Exp: Experience Req.: 11 - 16 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and knowledge on life cycle...
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Formulation Regulatory Affairs
2 days ago
Bengaluru, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Associate Manager / Manager - US Market Required Education/Exp: Experience Req.: 11 - 16 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and knowledge on life cycle...
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Regulatory Affairs Manager II
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Regulatory Affairs
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Regulatory Affairs Manager I
3 weeks ago
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Regulatory Affairs Manager I
2 weeks ago
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Regulatory Affairs Specialist
2 weeks ago
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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 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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Formulation Regulatory Affairs Specialist
1 week ago
Bengaluru, India Biocon Full timeKey ResponsibilitiesPreparation, review, and timely submission of ANDA in US market.Deficiency and life cycle management for the products filed in US.Review of technical (developmental and plant) documentations required for dossier submission.Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during...
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Formulation Regulatory Affairs Specialist
1 week ago
Bengaluru, India Biocon Full timeKey ResponsibilitiesPreparation, review, and timely submission of ANDA in US market.Deficiency and life cycle management for the products filed in US.Review of technical (developmental and plant) documentations required for dossier submission.Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during...
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Formulation Regulatory Affairs Specialist
1 week ago
Bengaluru, India Biocon Full timeKey ResponsibilitiesPreparation, review, and timely submission of ANDA in US market.Deficiency and life cycle management for the products filed in US.Review of technical (developmental and plant) documentations required for dossier submission.Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during...
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Regulatory Affairs Manager I
6 days ago
Bengaluru, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager ICareer Level - DIntroduction 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 Regulatory Affairs...
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Specialist- Regulatory Affairs
1 week ago
Bengaluru, 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 in...
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Regulatory Affairs Associate
7 days ago
Bengaluru, India Parexel Full time**Regulatory Affairs Associate** 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including: - Submission delivery strategy - Review of documents - Analysis of...
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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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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...