Assistant Manager, Regulatory Affairs

Amneal Pharmaceuticals


Date: 4 hours ago
City: Ahmedabad, Gujarat
Contract type: Full time
Job Description

  • Good knowledge of US ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
  • Exposure of the Solid oral dosage form/Liquid Oral/Transdermal dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects.
  • Ability to review the change cases with respect to ICH quality / post approval USFDA guidance and aware for Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling
  • Preparation and submission of controlled correspondence
  • Review and compilation of Annual Report with required submission data as per USFDA guidance.
  • Review and compilation of entire supplement/amendment submission package.
  • Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames and submissions.
  • Coordination with Cross Functional teams for the documents availability as per regulatory submission plan.
  • Ensure the no delay in drafting and compiling the regulatory submission.
  • Maintain regulatory information as per allocated task.
  • Having good Regulatory CTD modules drafting & review skills.

Education

 QUALIFICATIONS

  • B. Pharm B. Pharm - Required
  • M. Pharm M. Pharm - Preferred

Experience:

  • 8 years or more in 8 - 10 Years

Specialized Knowledge: Licenses:

How to apply

To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

Post a resume

Similar jobs

Sr. Design & Development Engineer

Ingersoll Rand Compressor Systems & Services, Ahmedabad, Gujarat
1 day ago
Ingersoll Rand is committed to achieving workforce diversity reflective of our communities. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion,...

Structural Engineer

Mott MacDonald, Ahmedabad, Gujarat
3 weeks ago
About the Business Unit:  Global Delivery Services Centre (GDSC) is a high-impact business unit within Mott MacDonald, dedicated to enhancing project delivery across our global operations.   As part of GDSC, you’ll join a team that champions excellence in both technical and digital disciplines, supporting projects at every stage of the lifecycle—from concept to completion. We work to international design standards...

Principal Physical Design Engineer

Astera Labs, Ahmedabad, Gujarat
3 weeks ago
Astera Labs (NASDAQ: ALAB) provides rack-scale AI infrastructure through purpose-built connectivity solutions. By collaborating with hyperscalers and ecosystem partners, Astera Labs enables organizations to unlock the full potential of modern AI. Astera Labs’ Intelligent Connectivity Platform integrates CXL, Ethernet, NVLink, PCIe, and UALink semiconductor-based technologies with the company’s COSMOS software suite to unify diverse components into cohesive, flexible systems that...