Ahmedabad, Gujarat, India
Posted: Nov 28, 2024
On-siteFull-time
Find Similar Recent Jobs
Share Job
Job Description
Job Description

  • Compile, prepare, review and submit ANDA submissions and Amendments to FDA with an overall objective to avoid major deficiencies and contribute to get approval within the shortest timeframes possible.
  • Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.
  • Must have expertise/prior experience in Sterile (Injectables/Ophthalmic) dosage form ANDAs.
  • Review / prepare documents which meet the requirement set forth by US FDA and accepted for review by FDA without query or RTR.
  • Evaluate change controls and formulates strategies for correct filing categories, with guidance from supervisor. Proactively raises major project issues if any to superior for resolution and agreement. Compile and submits critical post-approval supplements, such as CBE, CBE-30 and PAS as and when necessary.
  • Work very closely with all relevant departments at the time of product initiations, R&D phase, ANDA/Bio Execution and after initiation of stability to ensure timely availability of all documents to ensure timely submissions.
  • Prepare and finalize controlled correspondence to FDA on specific issues as needed for assigned projects.
  • Assess the deficiency letter immediately after receipt from FDA, perform in-detail gap assessment and discuss with superiors to finalize the strategy to respond the deficiency.

Qualifications

M. Pharm

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Share Job
Additional Info
Min. Experience
-
Job Location Type
On-site
Job Type
Full-time
Predicted Seniority Level
Mid-Senior level
Job Duration
-
Language(s)
All
Est. Budget/Pay Rate
To be discussed
Est. hrs
-
Optimal Job Start
-
Job Industry
Pharmaceutical Manufacturing
Job Function
Legal
Employer
Amneal Pharmaceuticals
Preferred Applicant Countries
India
Job Ref
J24DF8835693B
Disclaimer: The jobs on Lifelancer Platform are posted by employers, recruiters and Lifelancer. We aim to provide value to Talent users by connecting them with a maximum number of curated job opportunities. However, Lifelancer doesn't represent job-offering companies and is not responsible for job advert content or updates. We aim to connect you with the employer, job source, or application link to the best of our ability. You can apply for this job on the company website.