Regulatory Affairs Associate

7 months ago


Vadodara, India Aakashkamal Enterprises Full time

Position Regulatory Affairs Associates

Location - Vadodara

KRA:
As a RA Sr. Officer Reviewing artwork, PRAC variations, CEP updates for EU market.
Preparation of Regulatory Strategic documents for EU/UK market.
Review and compilation of deficiencies response for ROW (specially MENA, LATAM market)
Compilation and submission of renewal, variation for EU.
Well versed with all regulatory guidance requirement.
Initiating and compiling submissions, renewals and variations for product life cycle

management with different dosage forms such as tablets and syrup.
To co-ordinate with QA-QC and cross functional departments for compilation of technical

Experience: 2 - 6 Years

Salary - 3 Lacs - 7 Lacs

Joining ASAP

**Salary**: ₹25,000.00 - ₹55,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus
- Yearly bonus

Ability to commute/relocate:

- Vadodara, Gujarat: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 2 years (preferred)

**Speak with the employer**
+91 9824169451



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