Regulatory Affairs Job at MakroCare! Biotech & Life Sciences Apply
MakroCare
RA – I (Secondary Research)
Hyderabad, Telangana, India
About the job
Job Summary
We are seeking a skilled Research Analyst-I with a strong focus on Regulatory Affairs to provide detailed product profiles, regulatory intelligence, and comprehensive data analysis. The ideal candidate will have experience in secondary research within the context of regulatory bodies, clinical trials, drug development, and clinical studies.
This role requires expertise in gathering, evaluating, and analyzing scientific and legal data to stay updated on regulatory changes, aiding in drug and device development.
Key Responsibilities
- Secondary Research: Perform comprehensive secondary research to develop detailed profiles of drugs, medical devices, and clinical products.
- Data Compilation and Analysis: Collect and analyze data using modern and traditional research methods, organizing and synthesizing information from diverse sources.
- Document Analysis: Study scientific and legal documents to support product profiles and regulatory requirements.
- Information Management: Gather, evaluate, organize, and manage information from various formats including public reports, filings, clinical trial data, and company publications.
- Regulatory Compliance: Stay updated on changes in regulatory legislation and guidelines related to drugs, medical devices, and clinical studies.
- Data Analysis: Analyze complex scientific information, including clinical trial data, to provide insights into drug development and compliance.
- Labeling and Packaging: Outline requirements for the labeling, storage, and packaging of medical products to ensure compliance with regulatory standards.
- Intelligence Research: Conduct intelligence research on pharmaceutical and biotech companies, universities, and public organizations involved in drug research and development.
- Data Capture: Capture and update data on companies, clinical trials, and drug development from various sources including press releases, SEC filings, clinical trial reports, and scientific studies.
Education and Requirements
- Bachelor’s/Master’s Degree in Life Sciences, Biotechnology, Pharmacy, or a related field.
- 1-2 years of experience in secondary research with a focus on regulatory affairs.
- Proficiency in secondary research methods related to regulatory bodies, clinical trials, drug development, and clinical studies.
- Strong understanding of regulatory legislation and guidelines within the biotech and pharmaceutical industries.
- Familiarity with compiling and analyzing scientific data from public sources such as clinical trials, company reports, and NIH databases.
- Excellent analytical skills and the ability to handle and synthesize complex regulatory information.
Skills Required
- Strong secondary research skills, particularly in regulatory affairs.
- Ability to interpret and evaluate complex scientific and legal documents.
- Knowledge of drug development processes, clinical trials, and product compliance.
- Excellent written and verbal communication skills.
- Proficient in gathering and managing information from a variety of sources.
- High attention to detail and strong organizational skills.
- Ability to keep up with regulatory changes and trends in the pharmaceutical and biotechnology sectors.
Preferred Experience
- Previous experience working with regulatory bodies or authorities.
- Experience in analyzing clinical trial data and scientific reports.
Skills: secondary research, drug development, regulatory analysis, regulatory guidelines, regulatory affairs, literature reviews, data analysis.
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