Regulatory Affairs Executive

2 weeks ago

Mumbai Maharashtra, India Fiza Healthcare Pvt Ltd Full time

**Key Responsibilities**:

- **Regulatory Compliance & Monitoring**:

- Ensure that the company’s products comply with the regulatory requirements of the regions in which they are distributed.
- Stay current with national and international legislation, guidelines, and customer practices.
- **Regulatory Submissions & Documentation**:

- Prepare and submit regulatory dossiers, documents, and samples for participation in tenders, adhering to market-specific requirements.
- Collect, collate, and evaluate scientific data from various sources, preparing dossiers in CTD/ACTD formats as per market demands.
- **Product Registration & Approvals**:

- Monitor timelines for registration, variations, renewal approvals, and submissions to ensure timely completion.
- Follow up with the marketing team to ensure marketing authorization, registration data, and status are up-to-date.
- **Labeling & Documentation**:

- Write clear, accessible product labels and patient information leaflets to comply with regulatory standards.
- **Strategic & Advisory Role**:

- Provide strategic regulatory advice to senior management during new product development.
- Advise country sales managers on regulatory requirements to ensure market compliance.
- **Team Management & Collaboration**:

- Lead and manage teams of colleagues involved in the development of new products, ensuring adherence to regulatory processes.
- Work closely with cross-functional teams, including marketing, legal, and R&D, to ensure compliance.
- **Regulatory Audits & System Review**:

- Undertake and manage internal regulatory audits to ensure compliance with internal and external standards.
- Review company practices and advise on necessary changes to systems and procedures to align with regulatory requirements.
- **Stakeholder Liaison**:

- Liaise with regulatory authorities and stakeholders, including making presentations and participating in meetings as needed.
- **Packaging & Advertising Approvals**:

- Participate in the development of marketing concepts and approve packaging and advertising materials prior to product release to ensure they comply with regulatory standards.

Pay: ₹400,000.00 - ₹500,000.00 per year

**Benefits**:

- Paid sick time
- Paid time off
- Provident Fund

Work Location: In person

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