Regulatory Affairs Officer

19 hours 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**: ₹25,000.00 - ₹30,000.00 per month

Schedule:

- Morning shift

Supplemental Pay:

- Yearly bonus

**Education**:

- Doctorate (preferred)

**Experience**:

- total work: 5 years (preferred)

**Language**:

- English (preferred)

**Speak with the employer**

+91-XXXXXXXXXX

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