Regulatory Affairs Executive

1 week ago

Kolkata West Bengal, India Ayu Mantra Full time

This is an exciting opportunity to become part of an **innovative and dynamic team** dedicated to developing **high-quality natural health products** that positively impact consumers worldwide.

**Key Responsibilities**:

- **Regulatory Compliance & Licensing**: Prepare and submit regulatory dossiers for product registration and post-market changes, ensuring compliance with Health Canada and other regulatory bodies.
- **Scientific Documentation**: Compile and review **toxicology, efficacy, quality, and safety studies** for regulatory submissions.
- **Medical & Regulatory Writing**: Develop and refine **technical documents, label texts, and regulatory reports** as per international standards.
- **Data Analysis & Research**: Conduct **data mining and analysis** for regulatory submissions and compliance updates.
- **Monitoring & Certification**: Stay updated on regulatory changes and proactively seek new **certifications and supporting documents** for market expansion.

**Requirements**:

- **Master’s degree** in **Biological Sciences, Applied Biology, Pharmacology, or a related field.**:

- **3+ years** of hands-on experience in regulatory affairs, licensing, and certification procedures.
- Strong understanding of **botanical sciences, pharmacology, and natural health product regulations.**:

- Expertise in **scientific writing, analytical documentation, and regulatory submissions.**:

- Familiarity with **toxicology, efficacy studies, and human health safety documentation.**:

- Excellent **problem-solving and communication skills.**:

- **Basic computer proficiency** with experience in regulatory software tools is an advantage.

Pay: ₹35,000.00 - ₹40,000.00 per month

Schedule:

- Day shift

Application Question(s):

- How many years of work experience do you have using Dossier Preparation?
- How many years of work experience do you have using Herbal Medicine?

**Experience**:

- Total: 4 years (required)

Work Location: In person

Expected Start Date: 10/03/2025

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