Executive Regulatory Affairs - Mumbai, Maharashtra, India - EDGEPHARMA

Description

1) Complete understanding of requirements & regulations of ASEAN/ AFRICA/LATAM/ GCC/ MENA markets wrt New submissions, Re-registration & Variations.

2) Prior experience of carrying out high quality CMC review of all kind of technical documentation & Art-works,

3) Review and /or Compilation of country specific/ CTD/ACTD dossiers for new submissions & renewal.

3) Variations submission

4) Must be an Individual contributor + Good team player.


Specific requirements:
1) Collate, compile & author high quality CTD sections for M1, M2, M3, M4 & M5.

2) Detailed review of technical documents required for Regulatory submissions e.g. PVP/PVR/AMV/Stability report & Protocol/Specifications/ COAs/ BE study/ DMF etc.

4) Utmost care is recommended to minimize the unwanted errors while working with documents i.e. authoring & reviewing the data.


Must have Key Skills:
CTD/ ACTD/ CMC/ technical review/ Dossier/ MOH queries/ Variations/ Renewals


Other essential skills:
LATAM/ GCC/ MENA/ SEA/AFRICA/ change control/ Art work checking


Job Types:
Full-time, Permanent


Salary:
Up to ₹500,000.00 per year


Benefits:

• Leave encashment
• Provident Fund

Schedule:

• Day shift

Supplemental pay types:

• Yearly bonus

Education:

• Bachelor's (preferred)

Experience:

Regulatory Affairs: 3 years (required)
- total work: 4 years (required)