Amneal Pharmaceuticals Ltd - Urgent Openings in Regulatory Affairs (INJ / OSD)

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