Drug Regulatory Affairs

Dossier Preparation of Latam countries (El-Salvador, Guatemala,

Nicaragua)

Review guidelines of ROW countries.

Renewal Preparation of Latam countries

Handling commercial of ROW market.

Giving approval to PDLs, CCFs for commercialization.

Artwork management. (Review & give approval)

Review & release the FP specs and Q & Q formula for commercialization.

Co
- ordinate with different departments such as marketing dept, artwork

dept, QA dept, QC dept, ARD, FRD & Purchase dept.Quality Assurance - Review of BMR, Validations.

QC - Sterility testing, Microbiological testings, UV, HPLC, Leaker

test, Autoclave, Titration

Prduction of different dosage forms

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

**Salary**: ₹30,138.49 - ₹44,568.28 per month

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift
- Morning shift

Supplemental pay types:

- Performance bonus
- Yearly bonus

Ability to commute/relocate:

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

**Experience**:

- total work: 7 years (preferred)

Work Location: In person

**Speak with the employer**
+91 8923294366