1. Education:

• Bachelor’s degree in pharmacy, biology, chemistry, or related field. A master’s or certifications in regulatory affairs is a plus.

2. Experience:

• 1–3 years of experience in regulatory affairs or compliance (often in pharma, biotech, or medical devices).

3. Key Skills:

• Regulatory Knowledge: Familiar with guidelines like FDA, EMA, ICH.
• Attention to Detail: Accuracy in documentation and compliance checks.
• Project Management: Able to manage timelines and coordinate tasks.
• Communication: Strong writing and speaking skills for agency interactions.

4. Technical Proficiency:

• Skilled in Microsoft Office and regulatory submission tools.

5. Responsibilities:

• Prepare and submit regulatory documents.
• Ensure products meet standards and regulations.
• Communicate with regulatory agencies as needed.