Regulatory Affairs Officer

1 day ago

Odhav Ahmedabad Gujarat, India Nest Healthcare Pvt Ltd Full time

**Position**: Regulatory Affairs Specialist
**Location**: Odhav. Ahmedabad
**Department**: Regulatory Affairs
**Reports to**: Regulatory Affairs Manager / Director

Job Summary:
Key Responsibilities:

- **Compliance Monitoring**: Monitor changes in regulations and guidelines to ensure ongoing compliance with local and international regulations.
- **Cross-Functional Collaboration**: Collaborate with cross-functional teams, including R&D, quality assurance, and marketing, to gather necessary information for submissions.
- **Documentation Management**: Maintain accurate records of regulatory submissions and approvals, ensuring that all documentation is complete and up to date.
- **Regulatory Strategy**: Assist in the development and implementation of regulatory strategies for new product development and existing product modifications.
- **Communication**: Act as a liaison with regulatory agencies, responding to inquiries and addressing any issues that arise during the review process.
- **Training and Support**: Provide training and support to internal teams on regulatory requirements and compliance issues.

Qualifications:

- **Education**: Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field. A Master’s degree is a plus.
- **Experience**: Previous experience in regulatory affairs, preferably in the [insert industry, e.g., pharmaceuticals, medical devices, biotechnology].
- **Skills**:

- Strong understanding of regulatory guidelines and standards.
- Excellent written and verbal communication skills.
- Detail-oriented with strong analytical and problem-solving abilities.
- Ability to manage multiple projects and deadlines in a fast-paced environment.
- Proficient in Microsoft Office Suite and regulatory submission software.

Pay: ₹15,000.00 - ₹180,000.00 per month

Schedule:

- Day shift

**Experience**:

- total work: 2 years (required)

Work Location: In person

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