Urgent Opening in Regulatory Affairs
(INJ/OSD)-Amneal Pharma, Ahmedabad
Dear Candidate,
We are hiring for various positions
in Regulatory Affairs department. Please find below details for the same:
Position: Post approval
submission
Designation: Asst. Mgr / Sr.
Executive
Experience: 4-8 Years
Dosage Form: Solid oral (Tablet,
Capsules) & Liquid oral (Solution, Suspension)
Job Description:
· US
ANDA complete life cycle handling experience, specifically the supplements and
annual reports submissions
· Basic
Regulatory knowledge of Dosage forms incl.
· Solid
oral (Tablet, Capsules),
· Liquid
oral (Solution, Suspension),
· Basic
Knowledge of FDA guidance for Generic drugs
· ICH
Quality guidance - especially Stability and Impurity requirements
· Refuse
to receive and Stability Question & Answer guidance
· 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
· Clear
verbal and written communication skills
Position: Pre approval
submission
Designation: Asst. Mgr / Sr.
Executive
Experience: 4-8 Years
Dosage Form: Solid oral (Tablet,
Capsules) & Liquid oral (Solution, Suspension), Topical, Nasal
Job Description:
· Compile,
prepare, critically review and submit ANDA submissions and Amendments to FDA
with an overall objective to receive 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 Topical/Semi-solid, Liquid-oral, Solid-oral,
Nasal dosage form ANDAs.
· Ensure
timely submission of all assigned projects.
· Ensure
final ANDA meets 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.
· Proactively
raises major project issues to superior for resolution and agreement.
· Be
flexible in timings and intermittently available for t-cons as per US team
schedule.
· Evaluate
final compositions for IIG and Proportionality similar criteria's and develop
regulatory strategies to avoid acceptable for filing issues.
· Review
the API DMFs thoroughly and share the review comments to purchase department
on-time. Follow up with purchase team or with DMF holder directly as needed to
ensure compliance to provided comments on-time.
· Proof-read
and approve all OTC and Rx product labeling components.
Position: Pre approval
submission
Designation: Asst. Mgr / Sr.
Executive
Experience: 4-8 Years
Dosage Form: Injectable (Aseptic processing,
Terminal sterilization, Lyophilized products) Ophthalmic product, Complex
Products (Peptides, Microsphere), Combination products
Job Description:
· US
ANDA filing experience for sterile / injectable products including query
handling
· Regulatory
knowledge of Dosage forms including-
· Injectable
(Aseptic processing, Terminal sterilization, Lyophilized products)
· Ophthalmic
product
· Complex
Products (Peptides, Microsphere)
· Combination
products
· Knowledge
of FDA guidance for Generic drugs (eg. RTR guidance, ANDA content & format)
· Regulatory
strategy preparation
· Basic
knowledge of regulatory strategy for product (Controlled Correspondence, GDUFA
etc.)
· DMF
review
Interested candidate may forward their updated
cv at kavitriy@amnealindia.com
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