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: ₹20,000.00 - ₹30,000.00 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
