Data Associate Regulatory Information ArtiXio

1.0 - 5.0 years

0 Lacs

hyderabad, telangana

On-site

About Us: At Artixio, we support global pharmaceutical, biologics, and medical device companies in navigating complex regulatory landscapes. We are seeking a detail-oriented and driven Data Associate to support our regulatory information management initiatives by organizing, maintaining, and updating critical regulatory data and documentation. Key Responsibilities: Collect, review, and organize regulatory data from public health authority sources (e.g., US FDA, EMA, CDSCO, HSA, TFDA, NPRA, etc.). Extract and compile information on product approvals, classifications, guidelines, and regulatory requirements across markets. Maintain and update regulatory databases, trackers, and internal documentation with a high degree of accuracy. Perform periodic audits and quality checks to ensure data completeness, consistency, and compliance. Support regulatory affairs team in preparing documentation, summaries, and reports for internal and client-facing projects. Monitor and log updates in regulatory procedures, timelines, and dossier requirements from official sources. Required Skills & Qualifications: Bachelor's degree in Pharmacy, Life Sciences, Regulatory Affairs, Public Health, or a related field. 1-3 years of experience in regulatory affairs, data entry/management, or scientific documentation. (Freshers with strong skills may also apply.) Strong organizational and analytical skills with high attention to detail. Familiarity with regulatory authorities and global submission processes is preferred. Proficiency in MS Excel, Google Sheets; ability to handle structured data. Strong written communication skills and documentation discipline. Preferred Attributes: Interest in regulatory affairs, compliance, and document/data lifecycle management. Experience working with regulatory agency databases such as Drugs@FDA, EMA, or similar.,

Posted 2 weeks ago

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Project Technical Support III E Solutions

3.0 - 8.0 years

0 - 2 Lacs

Mumbai, Mumbai (All Areas)

Work from Office

Title of project:- Investigating Epigenetic factors involved in Mitochondrial Dysfunction in Obese PCOS Women under Dr. Pallavi Shukla Scientist D Department of Molecular Endocrinology ICMR-NIRRCH funded by Indian Council of Medical Research. Project position :- Project Technical Support III No. of vacancy :- 01 Consolidated Salary :- Rs.36,400/- (Rs.28000/- plus 30% HRA) Essential Qualification :- Three Years Graduate degree in Life Sciences/Microbiology/Biotechnology /Zoology/Bioanalytical Sciences + Three Years post qualification experience Post Graduation degree in Life Sciences/Microbiology /Biotechnology/Zoology Desirable / Job Responsibilities :- Desirable :- prior experience in reproductive health research, techniques related to mitochondrial dysfunction, pyrosequencing, bisulphite next generation sequencing and data analysis. scientific documentation, manuscript preparation, and writing or contributing to review articles. Job Responsibilities:- The selected candidate will be accountable for the comprehensive execution of the project, encompassing sample handling, experimental procedures, meticulous documentation of all activities and manuscript writing Age Limit :- 35 years 35 years One Year (further extendable for another two years) Duration :- One Year (further extendable for another two years) Posting Place :- ICMR-NIRRCH, J.M. Street, Parel, Mumbai 400012, Maharashtra. Interested Candidates can share their cv on this mail ID anchal.g@esolglobal.com

Posted 1 month ago

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