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Regulatory Affairs Officer

3 months ago

Mumbai, India Zieva Farm Pvt Lt Full time

Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
- Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications, Product packaging, Artwork etc.
- Provide expert regulatory input to in-licensing evaluations and due diligence activities
- Provide advice about regulations to manufacturers/scientists
- Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil standards
- Plan, undertake and oversee product Dossier, Samples, PIL etc and regulatory inspections if require.
- Keep up-to-date with changes in regulatory legislation and guidelines
- Write comprehensible, user-friendly, clear product information leaflets and labels,
- Liaise and negotiate with regulatory authorities, Regulatory departments of Pharma companies, Overseas Co-ordination with Pharmacist for Product release and address the quarries.
- B. Pharm or M. Pharm with at least 2-3 Years of Experience working in reputed Pharma Company for CIS region is preferable.
- Deep experience from pharmaceutical industry from a regulatory affairs perspective (Knowledge in OSD & Injectable will be an added advantage)
- Knowledge of ICH Guideline, CTD Dossier, Compliance of quarry submission, relevant guidelines, procedures and requirements
- Fluent in oral and written English

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

**Salary**: ₹30,000.00 - ₹35,000.00 per month

Schedule:

- Morning shift

Supplemental pay types:

- Yearly bonus

**Education**:

- Doctorate (preferred)

**Experience**:

- total work: 5 years (preferred)

**Language**:

- English (preferred)

**Speak with the employer**
+91 8898672024