Executive Regulatory Affairs
3 weeks ago
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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