Drug Regulatory Affairs

18 hours ago

Roorkee, India Lucent Biotech Ltd. Full time

**JOB RESPONSIBILITIES FOR PLANT DRA**

**Experience**:2-5 years
- Having experience in dossier preparation, compilation & review (CTD & ACTD) for CIS, ASEAN, LATAM, ROW & AFRICAN countries.
- Collaboration with internal departments (Production, QA, QC and other concerned departments) to compile quality documents timely, as per country specific requirements.
- Good liaisoning skill with customers and manufacturing unit.
- Dossier writing with focus on accuracy and adequacy of data.
- Preparation and review of responses to queries timely.
- Preparation and review of Variations and renewals as per country specific requirements.
- Stay up to date with the latest rules and regulations (ICH guidelines etc.)
- Collect, collate and evaluate scientific data from a range of sources.
- Work with specialist computer software and resources.
- Interview Venu : Sphurti Srivastava ( HR )
- 9532877108
- Job Types: Full-time, Regular / Permanent
- Salary: ₹20,000.00 - ₹25,000.00 per month

Job location: Roorkee

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

**Salary**: ₹15,000.00 - ₹20,000.00 per month

**Benefits**:

- Paid sick time

Schedule:

- Day shift

Supplemental pay types:

- Overtime pay

Ability to commute/relocate:

- Roorkee, Uttarakhand: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 2 years (preferred)

**Speak with the employer**
+91 9532877108

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