Regulatory Affairs Officer

**Job Description: Regulatory Affairs Officer - Pharmaceutical Manufacturing Industry**

**Position Overview**: The Regulatory Affairs Officer will be responsible for ensuring that all pharmaceutical products and processes comply with national and international regulations. This role involves preparing, submitting, and managing documentation for regulatory approvals, ensuring product registration, and maintaining compliance with regulatory standards across various markets.

**Key Responsibilities**:

- **Regulatory Submissions and Approvals**:

- Prepare and submit regulatory documents to health authorities (e.g., FDA, EMA) for product registrations, variations, renewals, and amendments.
- Maintain accurate and up-to-date regulatory files and documentation for all products.
- Coordinate and liaise with regulatory agencies during the approval process.
- **Regulatory Compliance**:

- Monitor and interpret changes in regulations and standards related to pharmaceutical manufacturing and products.
- Advise internal teams (R&D, quality assurance, manufacturing) on regulatory requirements for new products, formulations, and packaging.
- Ensure that all manufacturing processes, packaging, labeling, and product specifications comply with applicable laws and regulations.
- **Product Lifecycle Management**:

- Support regulatory activities throughout the product lifecycle, including pre
- and post-market compliance.
- Assist in managing product recalls, field alerts, and other compliance issues as necessary.
- Ensure timely renewals of product licenses and certifications.
- **Internal Collaboration**:

- Collaborate with cross-functional teams, including quality assurance, production, marketing, and research and development to ensure regulatory compliance is maintained throughout the product development and manufacturing stages.
- Provide regulatory guidance during product development and formulation.
- **Regulatory Intelligence**:

- Stay updated with global regulatory trends, guidelines, and practices.
- Provide strategic regulatory advice to facilitate timely market entry and minimize regulatory risks.
- **Training and Education**:

- Educate internal teams on regulatory requirements and best practices.
- Provide support and training on regulatory compliance and new regulations affecting the industry.

**Qualifications**:

- Bachelor's degree in Pharmacy, Life Sciences, or a related field (Master’s degree preferred).
- Minimum of 2-5 years of experience in regulatory affairs within the pharmaceutical manufacturing industry.
- In-depth knowledge of global regulatory guidelines (FDA, EMA, ICH, etc.).
- Strong understanding of pharmaceutical manufacturing processes and quality standards.
- Excellent communication and negotiation skills.
- Attention to detail and strong organizational abilities.

**Skills and Competencies**:

- Analytical and problem-solving skills.
- Ability to work under pressure and manage multiple projects simultaneously.
- Proficiency in regulatory submission software and tools.
- Knowledge of regulatory compliance software is a plus.
- Fluent in English, additional language skills are an asset.

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

Pay: ₹20,000.00 - ₹32,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Health insurance
- Internet reimbursement
- Leave encashment
- Life insurance
- Paid sick time
- Provident Fund

Schedule:

- Day shift
- Morning shift

Supplemental Pay:

- Yearly bonus

**Experience**:

- Regulatory Affairs (Pharma): 2 years (required)

Work Location: In person