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Associate - Regulatory Affairs (RegPoint)

icon building Company : Clinchoice
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Job Description - Associate - Regulatory Affairs (RegPoint)


Job Title: Associate – Regulatory Affairs (RegPoint)
Employment Type: Full-time (Permanent)
Location: Bengaluru, India
Work Type: Office-based
Experience: 0–1 year


About ClinChoice
ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.
Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.
We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.



Primary Responsibilities
•    Perform required data clean-up as per the defined process in the Regulatory Information Management System (RIMS).
•    Support business users by reviewing the data entered into the RIMS application and providing updates to users.
•    Complete assigned user requests on a daily basis as per the defined process.
•    Communicate with business users regarding queries related to user requests.
•    Process submission intake requests and ticket requests.



Secondary Responsibilities


•    Collect information from different sources and locations (manual and electronic), including supporting reports.
•    Enter collected information manually into RIMS for storage and analysis.
•    Perform peer quality checks of data entered against source documents.


Candidate’s Profile


•    Fresher or candidates with 3–6 months of experience in RIMS regulatory data management are preferred.
•    B.Pharm or M.Pharm qualification.
•    Proficiency in computer software and systems such as MS Office; exposure to Regulatory Information Management System (RIMS) software and document management tools is an added advantage.
•    Excellent communication skills in English, both written and verbal.


 


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