Executive - Regulatory Affairs - Mumbai

2 days ago

Mumbai Maharashtra, India Domnic Lewis Pvt. Ltd Full time

**Executive - Regulatory Affairs
- Mumbai**:
**Domnic Lewis has been mandated to hire for Executive - Regulatory Affairs
- Mumbai**

**Position Title**: Executive - Regulatory Affairs
**Grade**: C
**Reports to**: Lead/Manager - Regulatory Affairs

**Position Purpose**:

- Monitor and report the status of all product licenses in a timely and accurate manner
- Support the implementation of submission plans for new product registrations and ongoing product maintenance (e.g., amendments, renewals, updates)
- Manage SUGAM portal submissions as assigned
- Prepare and coordinate responses to queries from health authorities
- Maintain regulatory trackers, documentation, and archival systems
- Provide regulatory documentation support for tender processes

**Key Internal Stakeholders**:

- Marketing, Sales, Logistics
- Medical Affairs, Legal Affairs, Intellectual Property
- Clinical Operations, Product Teams, Brand Teams
- International Regulatory Affairs, QA, Manufacturing Sites, Regional Offices

**Key External Stakeholders**:

- Local Health Authorities
- Relevant Government Agencies

**Minimum Requirements**:

- **Qualification**: M.Pharm / B.Pharm / M.Sc
- **Experience**: 2-3 years in Indian Regulatory Affairs
- **Knowledge**: Familiarity with dossier compilation and current Indian regulatory guidelines

**Key Result Areas and Outputs**:
**1. Regulatory Compliance and Ethics**:

- Ensure alignment with company values, applicable legislation, and industry codes of conduct
- Adhere to corporate governance, audit requirements, and ethical practices
- Maintain confidentiality of sensitive company and product information
- Report any potential violations of codes or conduct standards

**2. Licensing and Documentation**:

- Monitor and track the status of all product licenses
- Coordinate updates or changes in licenses, ensuring timely communication and documentation
- Maintain organized and updated records and trackers

**3. Regulatory Strategy and New Product Launches**:

- Understand product strategy, dossier content, and regulatory intelligence
- Contribute to the planning and execution of regulatory strategies for new launches
- Ensure timely submissions and approvals for rapid market entry

**4. Cross-functional Collaboration**:

- Work closely with cross-functional teams (e.g., QA, Supply Chain, Clinical Ops, Medical, Market Access)
- Coordinate with international and regional regulatory colleagues
- Take ownership of assigned projects with mínimal supervision
- Support onboarding and mentoring of junior team members or contract associates

**5. Life Cycle Management**:

- Ensure timely compliance submissions for both commercial and clinical trial products
- Support audits and manage deviations or CAPAs as required
- Assist in import registration/renewal and production transfers
- Review and support packaging/artwork updates and local licensing

**6. Clinical Trial Support**:

- Manage submissions, responses, and approvals for clinical trials, including Phase IV and PMS studies
- Ensure compliance throughout the study lifecycle, from initiation to closure
- Prepare for Subject Expert Committee (SEC) reviews and meetings

**7. Competitive Intelligence**:

- Monitor global pipelines and regulatory trends of competitor companies
- Assess potential impact on internal development plans and provide strategic input as required

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