Drug Regulatory Affair, Executive

1 week ago

Dehradun Uttarakhand, India Sanidhya Sansar Ventures Full time

**Position Overview**: The Drug Regulatory Affairs Executive plays a critical role in ensuring that pharmaceutical products meet all regulatory requirements. This position involves collaboration with various departments to support the development and approval of drug products, ensuring compliance with local and international regulations.

**Key Responsibilities**:

- **Regulatory Compliance**:

- Ensure that all drug products comply with relevant laws and regulations.
- Maintain up-to-date knowledge of regulatory changes and industry standards.
- **Submission Management**:

- Prepare and submit regulatory documents (INDs, NDAs, BLAs) to health authorities.
- Manage timelines and ensure timely submission of all regulatory filings.
- **Cross-Functional Collaboration**:

- Work closely with R&D, Quality Assurance, and Marketing teams to support product development.
- Provide regulatory guidance and expertise during product lifecycle management.
- **Clinical Trials**:

- Ensure compliance with Good Clinical Practice (GCP) and related guidelines.
- **Labeling and Product Information**:

- Review product labeling and promotional materials to ensure compliance.
- Collaborate with marketing to ensure accurate and compliant product information.
- **Audits and Inspections**:

- Prepare for and participate in regulatory inspections and audits.
- Address findings and implement corrective actions as necessary.
- **Risk Assessment**:

- Conduct risk assessments related to regulatory issues.
- Develop strategies to mitigate risks associated with product approvals.

**Qualifications**:

- **Education**: Bachelor’s degree in Pharmacy, Life Sciences, or related field; advanced degree preferred.
- **Experience**: 3-5 years of experience in regulatory affairs within the pharmaceutical industry.
- **Knowledge**: In-depth understanding of pharmaceutical regulations, guidelines, and processes (FDA, EMA, etc.).
- **Skills**:

- Strong analytical and problem-solving abilities.
- Excellent communication and interpersonal skills.
- Proficiency in regulatory submission software and Microsoft Office Suite.

**Personal Attributes**:

- Detail-oriented with a strong commitment to compliance.
- Ability to work independently and as part of a team.
- Strong organizational and project management skills.

**Career Path**: Potential advancement opportunities include Senior Regulatory Affairs Executive, Regulatory Affairs Manager, or Director of Regulatory Affairs.

**Location**: In Person.

**Job Types**: Full-time, Permanent

Pay: ₹25,000.00 - ₹40,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Health insurance
- Internet reimbursement

Schedule:

- Day shift

Supplemental Pay:

- Performance bonus
- Yearly bonus

**Experience**:

- Regulatory reporting: 3 years (required)

Work Location: In person

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