Regulatory Affairs Officer

2 weeks ago

Hanuman Nagar Nagpur Maharashtra, India Genetek Lifesciences Private Limited Full time

**Key Responsibilities**:

- **Regulatory Compliance**:

- Ensure that the company’s pharmaceutical products comply with all applicable regulations (FDA, CDSCO).
- Keep up-to-date with changes in regulatory legislation and guidelines and communicate them to the relevant departments.
- **Documentation & Submission**:

- Prepare, compile, and submit documentation for CTD, Non-CTD dossiers.
- Ensure timely submission of product licenses, renewals, and variations.
- **Regulatory Strategy**:

- Develop regulatory strategies to obtain approvals in a timely and cost-effective manner, considering global regulations and guidelines.
- Collaborate with cross-functional teams (R&D, Quality, Clinical, Marketing) to align regulatory strategies with business objectives.
- **Communication with Regulatory Authorities**:

- Serve as the primary contact between the company and regulatory agencies.
- Respond to queries from regulatory agencies and facilitate the approval process by providing additional information when needed.
- **Product Labeling and Advertising Compliance**:

- Review and approve product labeling, packaging, promotional materials, and advertising to ensure compliance with regulatory requirements.
- Ensure that product labels accurately reflect approved indications, usage, warnings, and safety information.
- **Clinical Trials & Product Development**:

- Assist in the regulatory aspects of clinical trials, ensuring compliance with Good Clinical Practices (GCP) and the submission of trial-related documentation.
- Provide regulatory input throughout the product development process to ensure that all activities comply with regulatory requirements.
- **Post-Market Surveillance & Reporting**:

- Oversee post-market surveillance activities, including the reporting of adverse events, product recalls, and safety updates.
- Ensure compliance with pharmacovigilance and risk management regulations.
- **Regulatory Intelligence & Risk Management**:

- Monitor and assess the impact of new or revised regulations and guidelines on the company’s products and operations.
- Advise senior management on potential risks and opportunities related to regulatory issues.
- **Inspection & Audits**:

- Prepare and participate in regulatory inspections and audits.
- Ensure the company maintains records of all regulatory approvals and associated documentation for future reference.
- **Collaboration & Training**:

- Work closely with the research and development, manufacturing, and quality assurance teams to ensure product development aligns with regulatory requirements.
- Provide training and guidance to internal teams on regulatory issues and requirements.

Pay: ₹180,000.00 - ₹1,119,361.64 per year

Schedule:

- Day shift

**Experience**:

- total work: 2 years (preferred)

Work Location: In person

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