Amneal Pharmaceuticals is a high-quality producer of solid and Injectable generic products and one of the fastest-growing global generics producers. We believe that the world is our family and we are committed for consistently producing high quality affordable medicines. Amneal is expanding its operations in India and invites people who share its value of relentless pursuit of quality, integrity, treating each other with respect and encouraging the very best in everyone to join the Amneal family.
Amneal have opportunity for Regulatory Affairs – Injectable based at Ahmedabad location. Request to find below the required details:
Department: Regulatory Affairs
Required Experience: 04-12 Years
Position: Senior Executive / Asst. Manager / Manager
Job Location: Ahmedabad
Job Description:
• Experience in submission of ANDA and FDA query responses for Sterile products, 505b2, Complex products (including Peptides), Drug-Device combination products, and Ophthalmic and Otic Products.
• Review of literature and preparation of Regulatory Strategy for Sterile products development and submission for USA, Europe, and Canada Market
Preparation of Controlled Correspondences, packages for FDA meetings, and Scientific advice.
Review of documents with respect to compliance with Regulatory guidelines and submission requirements.
Preparation and submission of the quality dossier/ANDAs within the stipulated timeline.
• Primary review of DMFs and follow up with the concerned team to get all required documentation.
If interested, please share your CV at kavitriy@amneal.com mentioning the subject line “Application for Regulatory Affairs – Injectable”
Freshers and candidate from other departments, please don’t apply.
Amneal have opportunity for Regulatory Publishing based at Ahmedabad location. Request to find below the required details:
Required Experience: 01-05 Years
Position: Officer / Executive
Job Location: Ahmedabad
Job Description:
• PDF processing, QC Check and CTD/ e-CTD compilation for US market
• Submission Level Publishing for US Market.
• Archival and life cycle management of the CTD/e-CTD submission.
If interested, please share your CV at kavitriy@amneal.com mentioning the subject line “Application for Regulatory Operations”
Freshers and candidate from other departments, please don’t apply.
Amneal have opportunity for Regulatory Affairs – OSD/Topicals based at Ahmedabad location. Request to find below the required details:
Required Experience: 03-07 Years
Position: Executive / Senior Executive
Job Location: Ahmedabad
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 Topical/Semi-solid, Liquid-oral, Solid-oral, Nasal and/or transdermal dosage form ANDAs.
• Ensure timely submission of all assigned projects.
• 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.
If interested, please share your CV at kavitriy@amneal.com mentioning the subject line “Application for Regulatory Affairs – OSD/Topicals”
Freshers and candidate from other departments, please don’t apply.
Amneal have opportunity for Technology Transfer (R&D-Injectable) / MS&T – Manufacturing Plant based at Ahmedabad location. Request to find below the required details:
Required Experience: 02-06 Years (Candidates having Manufacturing Injectable experience can also apply)
Position: Officer / Executive
Job Location: Ahmedabad (Manufacturing Plant)
Job Description:
• Responsible for Preparation of Master BMR, BPRs and document management.
• Responsible for coordination with various departments like Regulatory Affairs, Manufacturing, Warehouse, Quality Assurance, Quality Control, Engineering for execution of Scale-up and Exhibit batches.
• Responsible for reviewing GMP related documents.
• To facilitate the Change Controls to be logged for various reasons. To initiate the Change Controls due to revision in BMR / BPRs and other PD related changes.
• To study critical parameters during scale up batches to optimize the CPPs and CQAs.
• To provide the input related to batch size, process feasibility & process parameters to formulation scientist as per requirement.
• To monitor and ensure readiness for execution of scale-up / feasibility batches, Exhibit batches with respect to RM, PM & Miscellaneous items.
• Responsible for reviewing GMP related documents as applicable.
• Activities other than the defined in the Job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance.
To get actively involve in Scale-up and Exhibit batches.
If interested, please share your CV at kavitriy@amneal.com mentioning the subject line “Application for MS&T / Technology Transfer”
Freshers, please don’t apply.
Amneal have opportunity for “Extractable & Leachable Expert” based at Ahmedabad location. Request to find below the required details:
Required Experience: 04-09 Years
Position: Asst. Manager / Manager
Job Location: Ahmedabad
Job Description:
• Review of Extractable Leachable Protocols and Reports for all Regulatory submissions for different dosage forms and provide/discuss comments with cross functional team.
• Review of E&L Protocols/ Reports with respect to compliance to regulatory guidelines, Identifying the critical gaps, reviewing and finalizing the tox. assessment for leachable above AET.
• To file high-quality reports that would help to avoid major queries on E&L and facilitate faster approvals so as to meet management expectations.
If interested, please share your CV at kavitriy@amneal.com mentioning the subject line “Application for Extractable & Leachable Expert Role”
Freshers and candidate from other departments, please don’t apply.
Amneal have opportunity for Project Management (Emerging Market) – Corporate Office based at Ahmedabad location. Request to find below the required details:
Required Experience: 05-09 Years
Exposure Required: Experience of Emerging Market (Africa, LATAM, MENA & SEA etc.) is must.
Position: Assistant Manager
Job Location: Corporate Office – Ahmedabad
Job Description:
• Develop project plans for all aspects of assigned projects and manages all activities.
• Lead cross functional project teams and status meetings.
• Monitors and manage project scope, budget, forecast, resources and deliverables within timeline.
• Provides timely, comprehensive project status reports, including budget and timelines.
• Proactively identifies significant project risks, develop mitigation strategies, escalates to leadership and implements approved mitigation steps.
If interested, please share your CV at kavitriy@amneal.com mentioning the subject line “Application for Project Management”
Freshers, please don’t apply.
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