Data Associate – Regulatory Information

4 weeks ago

Hyderabad, Telangana, India ArtiXio Full time
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.

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