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Krishma Thakur

Hyderabad Telangana, India

Phone: xxx-xxx-xxxx

Email: xxx@xxxx.xxx



  • Looking For: M.Pharmacy, regulatory affairs specialist

  • Occupation: Healthcare

  • Degree: Master's Degree

  • Career Level: Experienced

  • Languages: English, Hindi

Career Information:

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Highlights:Regulatory Affairs professional with 1.6 years of experience in EU submissions and global regulatory requirements, concentrating on CTD quality section compilation and review. Experience in regulatory data analysis and project management.

Skills:

Goal:to secure a challenging role in the regulatory affair department that fosters growth, innovation, and continuous learning, while driving regulatory excellence and compliance.


Experiences:

Regulatoary Affair Executive 08/2023 - current
Jodas Expoim Pvt. Ltd., Hyderabad, Telangana India
Industry: Pharmaceutical
Regulatory Affairs professional with 1.6 years of experience in EU submissions, concentrating on CTD quality section compilation and review. Aspiring to contribute my regulatory expertise in a challenging role that fosters growth, innovation, and continuous learning, while driving regulatory excellence and compliance.
In my current role, I work on compiling and reviewing CTD Quality Sections, DMFs, and CMC documents to ensure compliance with EU and global regulatory requirements. I collaborate closely with cross-functional teams to streamline data collection and support regulatory projects, ensuring timely and accurate submissions. I am well versed with ICH guidelines, have great written and verbal communication skills. I am a hardworking, quick learner and enthusiastic individual. Also well versed with various Microsoft office applications (Word, PPT, Projects) & Adobe Acrobat. I am particularly drawn to the opportunity to learn and explore more. I am truly passionate about advancing expertise in regulatory intelligence, operations, and global compliance--

Education:

Panjab University 10/2021 - 7/2023
Chandigarh, Chandigarh, India
Degree: Master's Degree
Major:Quality Assurance
M.Pharmacy in Quality Assurance.


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