MakroCare is a global consulting and solutions provider, specializing in regulatory affairs, clinical research, and healthcare solutions. With years of expertise, the company works with global regulatory bodies such as the FDA and EMA, supporting product development and compliance for pharmaceutical and medical device companies.
Key Responsibilities of the Regulatory Affairs Analyst
As a Regulatory Affairs (Data) Analyst at MakroCare, you will play a vital role in ensuring compliance with evolving industry standards. Below are the core responsibilities for this position:
- Regulatory Research
- Conduct secondary research on regulatory requirements for drugs, medical devices, and clinical trials.
- Stay updated with changes in global regulations, including those from the FDA, EMA, and other international authorities.
- Compliance Monitoring
- Track regulatory developments to ensure products align with the latest compliance requirements.
- Perform regulatory intelligence gathering and monitor market trends impacting compliance.
- Data Analysis and Documentation
- Analyze clinical trial and regulatory data to ensure compliance with industry standards.
- Study and review scientific, legal, and regulatory documents to support regulatory filings.
- Information Management
- Organize and manage data from regulatory filings, clinical trials, and public reports.
- Assist with product compliance by maintaining a structured database of regulatory data.
Qualifications and Requirements
MakroCare is seeking candidates who are skilled in regulatory affairs and data analysis. Here are the essential qualifications required for the role:
- Educational Background:
Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Pharmacy, or a related field. - Experience:
- 2-3 years of experience in regulatory-focused secondary research.
- Prior experience working with global regulatory bodies and interacting with relevant authorities.
- Knowledge and Expertise:
- Strong understanding of regulatory guidelines for pharmaceuticals, medical devices, and clinical trials.
- Experience in regulatory intelligence, compliance monitoring, and secondary data analysis.
Key Skills for Success
To excel in this role, candidates should have the following skills:
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- Global Regulatory Compliance: Familiarity with guidelines from FDA, EMA, and other bodies.
- Data Analysis Expertise: Ability to analyze scientific and regulatory data effectively.
- Regulatory Documentation Skills: Proficiency in regulatory standards, filings, and monitoring.
- Attention to Detail: High precision in ensuring compliance with industry regulations.
- Information Management: Experience in managing regulatory documents and clinical trial data.
