Regulatory Affairs Executive
1 week ago
Key duties of the job include:
- studying scientific and legal documents
- gathering, evaluating, organising, managing and collating information in a variety of formats
- ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA) viz, CDSCO, FDA, WHO-GMP, CE certification.
- maintaining familiarity with company product ranges
- planning, undertaking and overseeing product trials and regulatory inspections - keeping up to date with changes in regulatory legislation and guidelines
- analyzing complicated information, including trial data
- offering advice about company policies, practices and systems
- obtaining marketing permission
- outlining requirements for labelling, storage and packaging
- liaising and negotiating with regulatory authorities
- providing advice about regulations to manufacturers/scientists
- writing comprehensible, user-friendly, clear product information leaflets and labels
- ensuring that quality standards are met and submissions meet strict deadlines - preparing documentation.
- Performs other related duties as assigned.
- Ensuring compliance with all regulatory requirements
- Maintaining regulatory documentation database
- Assisting with the preparation and submission of all regulatory reports
- Providing accurate reviews of data and reports
- Ensuring accurate and timely submissions to regulatory agencies
**Salary**: From ₹40,000.00 per month
**Benefits**:
- Provident Fund
Schedule:
- Morning shift
Ability to commute/relocate:
- Vasai, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 4 years (preferred)
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