Executive Regulatory Affairs

3 weeks ago


Andheri Mumbai Maharashtra, India Eway IT Solutions Full time

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 deliverable 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 - ₹40,000.00 per month

**Benefits**:

- Flexible schedule

Schedule:

- Flexible shift
- Monday to Friday
- Morning shift

Supplemental pay types:

- Performance bonus
- Yearly bonus

Ability to commute/relocate:

- Andheri, Mumbai, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 5 years (preferred)

**Speak with the employer**
+91 9522202425



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