Regulatory Affairs Executive

2 months ago

Sachin Surat Gujarat, India Globela Pharma Pvt. Ltd. Full time

**Job Description: Regulatory Affairs Executive (Fresher to 3 Years Experience)**

**Position**: Regulatory Affairs Executive

**Department**: Regulatory Affairs

**#### **Key Responsibilities**:

- **Regulatory Submissions**:

- Prepare and submit regulatory documents to health authorities (FDA, EMA, TGA, etc.) for new products, amendments, and renewals.
**- **Compliance Monitoring**:

- Ensure compliance with local and international regulations for pharmaceutical products throughout their lifecycle (from development to market authorization).
- Monitor changes in regulatory guidelines and standards, and inform the team about relevant updates.
**- **Documentation and Reporting**:

- Compile and maintain accurate regulatory documentation in line with regulatory requirements.
- Prepare and submit periodic reports for ongoing regulatory activities.
**- **Labeling and Packaging**:

- Review product labeling, packaging, and advertising materials for regulatory compliance.
- Collaborate with cross-functional teams (R&D, Marketing, Legal) to ensure regulatory compliance for all promotional materials.
**- **Communication with Regulatory Authorities**:

- Liaise with regulatory bodies regarding product approvals, queries, and inspections.
- Respond to questions or requests from health authorities in a timely manner.
**- **Cross-Functional Support**:

- Work closely with the R&D, Quality Assurance, and Commercial teams to provide regulatory guidance on new product development, clinical trials, and marketing activities.
**- **Regulatory Intelligence**:

- Stay updated on new regulations, guidelines, and industry trends to anticipate potential challenges in the regulatory process.
**- **Project Management**:

- Manage timelines and coordinate tasks associated with regulatory submissions and approvals.
- Ensure the timely approval and launch of products by working in close coordination with other departments.

**#### **Requirements**:

- **Educational Qualifications**:

- Bachelor's or Master's degree in Pharmacy (BPharm / MPharm)
**- **Experience**:

- **Fresher to 3 years of experience** in Regulatory Affairs, Pharmaceutical Industry, or related field.
- Experience in regulatory submissions, compliance, and dossier preparation is a plus but not required for freshers.
**- **Skills and Competencies**:

- Strong understanding of pharmaceutical regulations (FDA, EMA, ICH, etc.).
- Good knowledge of regulatory submission processes and documentation requirements.
- Attention to detail and excellent organizational skills.
- Strong written and verbal communication skills.
- Ability to work in a team environment and collaborate with cross-functional teams.
- Proficient in Microsoft Office Suite (Excel, Word, PowerPoint).

Pay: ₹15,000.00 - ₹30,000.00 per month

**Benefits**:

- Paid time off

Schedule:

- Day shift

**Experience**:

- total work: 1 year (required)

Work Location: In person

Application Deadline: 15/11/2024
Expected Start Date: 30/11/2024

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