Senior Regulatory Affairs Associate
Found in: beBee S IN - 2 weeks ago
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Skills
- Preparation and submitting Clinical Trial Application and amendments
- Hands on experience for CT-04 and Form CT-16 filling on SUGAM portal
- Preparation of SEC meeting documentation
- Sound knowledge of New Drugs & Clinical Trials Rules_2019
- Handling queries raised by DCGI pertaining to regulatory submissions
- Comprehensive regulatory requirement for Investigational new drug, New drug and Product life cycle management.
Knowledge and Experience:
- 6-9 years of experience in an industry-related environment
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Regulatory Affairs Associate
Found in: beBee S IN - 2 weeks ago
Bengaluru, India Parexel Full timeRegulatory Affairs Associate 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.• To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.• To provide regulatory input on procedural and CMC documentation...
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Regulatory Affairs Associate
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Regulatory Affairs Associate
Found in: beBee jobs IN - 2 weeks ago
Bengaluru, Karnataka, India Parexel Full timeRegulatory Affairs Associate 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.• To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.• To provide regulatory input on procedural and CMC documentation...
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Found in: beBee S IN - 4 weeks ago
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Senior Regulatory Affairs Associate
Found in: beBee jobs IN - 1 week ago
Bengaluru, Karnataka, India Parexel Full timeSenior Regulatory Affairs Associate-Biologics Around 4-8 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresContribute to...
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Found in: beBee S IN - 2 weeks ago
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Found in: beBee S IN - 3 weeks ago
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Regulatory Affairs Consultant
Found in: beBee S IN - 2 weeks ago
Bengaluru, India Parexel Full timeRegulatory Affairs Consultant:Around 7-10 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologicals) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute to the...
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Found in: beBee jobs IN - 1 week ago
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Found in: Talent IN C2 - 2 weeks ago
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Found in: beBee jobs IN - 1 week ago
Bengaluru, Karnataka, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at...
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Found in: Talent IN C2 - 2 weeks ago
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Found in: Talent IN C2 - 2 weeks ago
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Found in: Talent IN C2 - 1 week ago
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