Saturday, May 22, 2021

Amneal Pharmaceuticals hiring Msc Bpharm Mpharm for Multiple openings

 Amneal Pharmaceuticals Recruitment 2021.Amneal Pharmaceuticals Notification full detailes below. Amneal Pharmaceuticals, Inc. is an American publicly traded generics and specialty pharmaceutical company. The company is headquartered in Bridgewater, New Jersey. 


Important Vacancy details:Amneal Pharmaceuticals Hiring MSc,B.pharm,M.Pharm for Regulatory Affairs-US Market AT Ahmedabad.Interested and eligible candidates can Apply Now.Interested candidate can share their cv on kavitriy@amnealindia.com

  1. Post Name: Regulatory Affairs-US Market
  2. Education:MSc, B.pharm, M.Pharm.
  3. Experience:3-8 years
  4. Location: Ahmedabad
  5. Salary:3,00,000 – 8,00,000 P.A.
  6. Openings:NA

Note:If interested candidates can share your resume to mentioned mail ID Below. you can share cv on  kavitriy@amnealindia.com

 Job Description:Greetings from Amneal Pharma !!

Function: RA – Pre Approval (OSD / Topical / Injectable – US Market)
Position: Executive / Sr. Executive
Experience: 3 – 8 Years

Job Responsibilities:

1. US ANDA filing experience including handling of query raised by FDA 
•        Knowledge of FDA guidance for Generic drugs
•        Knowledge of ICH Quality guidance especially Stability and Impurity requirements
2. Should have exposure to Topical dosage form (eg., Creams, Gels, Ointments, Lotions, & Solutions etc.) related ANDA requirements for US market
o  Qualitative and Quantitative assessment of topical dosage form
o  Basic knowledge of rheology (Viscosity), diffusion, etc.
o  Basic knowledge of Suitability/compatibility study of packaging components
o  Critical quality attributes (CQA) of topical dosage form
o  Stability requirements incl. conditions and orientation
3. Basic knowledge of Refuse to receive and Stability Question & Answer guidance
4. Basic knowledge of Controlled Correspondence
5. Formulation development and IIG assessment

Function: RA – Post Approval (OSD – US Market)
Position: Executive / Sr. Executive
Experience: 3 – 8 Years

Job Responsibilities:1. US ANDA complete life cycle handling experience, specifically the supplements and annual
reports submissions
• Basic Regulatory knowledge of Dosage forms incl.
o Solid oral (Tablet, Capsules),
o Liquid oral (Solution, Suspension),
• Basic Knowledge of,
o FDA guidance for Generic drugs
o ICH Quality guidance especially Stability and Impurity requirements
o Refuse to receive and Stability Question & Answer guidance
o SUPAC guidance, supplement and Annual report related FDA guidance
• Post approval CMC experience is highly desirable.
• Experience of handling change control assessment (via Track wise, QUMAS if explored), and
accordingly prepare and submit relevant CBE0, CBE30, PAS, Annual Reports
• Review batch records, annual reports and CMC documents
• Coordinate work with CMO, Regulatory CFT teams for regulatory submissions

Function: RA – Labelling (US Market)
Position: Executive / Sr. Executive
Experience: 3 – 7 Years

JOB RESPONSIBILITY:

1. Labeling part of Original ANDAs

2. Amendments (DRL/IR/CR)

3. Labeling Supplements:

  • To prepare and review below labeling components.

a. RLD word documents;

b. Amneal Redline;

c. Labeling SBS (side-by-side) of Package insert and carton/container labeling.

d. Revise Structure Product Labeling (SPL);

  • To ensure FPL (Final Printed Label) is available for submission.
  • If there is any revision in RLD Carton/Container labelling that must be incorporated in Amneals Artwork through CCF.
  • To ensure current version of Container/Carton/Blister label is available for Ok-to-print activity.
  • To ensure that labeling modules are available for submission.

2. Site-Transfer Projects:

  • Preparation and review of labeling component of site transfer projects [i.e. word file, Redline, Clean file, Structured Product Labeling (SPL)].
  • To ensure availability of all artwork (FPL, container, carton and blister label) and review the same.

3. CCF:

  • Initiate change controls as and when required for labeling changes.

4. Cover Letter and 365h Form:

  • To prepare and review Cover Letter and 365h form for all supplements.

5. Proof Reading:

  • Proof reading of soft copy, hard copy, transparency, shade cards and first print of all labeling components.

6. Annual Reportable Changes (Labeling):

  • To compile and review annual reportable change received from the agency in supplement approval letter and all Annual Reportable changes are submit in next Annual Report cycle.

Interested candidates may share their updated CV at kavitriy@amnealindia.com

Selection ProcessThe selection will be based On Interview.

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