Amneal pharmaceuticals We are having multiple positions in following departments: Regulatory Affairs - Injectable Regulatory Affairs - OSD Analytical R&D - Injectable Formulation & Development - Injectable

Amneal pharmaceuticals, Ahmedabad-GUJARAT

We are having multiple positions in following departments:

Regulatory Affairs - Injectable
Regulatory Affairs - OSD
Analytical R&D - Injectable
Formulation & Development - Injectable
Note: People from Non-regulated plant are not eligible.
Please find below the job description for each position:

1. Regulatory Affairs - Injectable

Executive:
Exp: 3-4 Yrs
Qualification: M.Sc / B. Pharma
Must have exposure of Labeling software for USA market.
Injectable background will be more preferable

2. Sr Executive
Exp: 7-8 Yrs
Qualification: M.Sc / M. Pharma
Handling US Labeling both at pre-approval & post approval stage
Should be conversant with labeling related software
Understanding of packaging operations in shopfloor.

3. Regulatory Affairs (Injectable):

Position: Sr Exe to Manager
Exp: 4-9 Yrs
Qualification: M. Pharma
Must be from Injectable background.
Have good exposure of CMC tools.
Must have working exposure for USA / EU market.

4. Regulatory Affairs - OSD / Solid Oral

ANDA Amendments:
Position: Sr Exe / Asst Manager
Exp: 4-8 Yrs
Qualification: M. Pharma / M.Sc
Good understanding of GDUFA process.
Should be able to coordinate with cross functional team to finalise deficiency responses.
Should be good technical writer

5. DMF
Position: Manager
Exp: 6-9 Yrs
Quali: M. Pharma / M.Sc
Should be able to handle complete Type II API DMF lifecycles (Includes Review of original DMF, DMF amendments and annual reports)
Good understanding of GDUFA process and electronic activities.

6. ANDA Post Approval Submission:
Position: Manager
Exp: 6-10 Yrs
Quali: M. Pharma / M.Sc 
Should be able to handle post approval submissions like PAS, CBE-30, CBE-0, Annual reports.
Will work with cross functional team.

7. ANDA e-CTD experts
Position: Manager
Exp: 5-8 Yrs
Quali: M. Pharma/ B. Pharma / M.Sc
Should be able to handle all electronic submission activities for ANDA life Cycle.
Must be an expert on e-CTD software

8.Position: Manager
Exp: 6-10Yrs
Qualification: B. Pharma / M.Sc
Should be able to handle US labeling activities including labeling module compilation and review for original ANDA, ANDA amendments. 
Finalization of US Labeling Artwork.

9. Analytical R&D & Formulation-Development:
Must have exposure of Injectable ARD & Injectable F&D only
Should be from Regulated plant only

Please do not apply in case having exposure of OSD plant.

Request to send CV at 

pujas@amnealindia.com