Amneal 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.
Multiple Opening – Regulatory Affairs | USA Mkt | Amneal Pharma, Ahmedabad.
Job description:
Regulatory Affairs Pre Approval / Post Approval | Injectable | US Market Only
- Experience – 03 – 10 Years
- Designation – Executive / Senior Executive / Assistant Manager / Deputy Manager
Job Description:
- New Injectable product & 505 b2 submissions for USA, Europe, Canada, and any other assigned markets.
- Provide regulatory strategy/inputs during product development for Injectable, Ophthalmic, and Complex Products etc. to R&D and other cross-functional teams for adequate data generation.
- Evaluation and submission of Pre-IND/Pre-ANDA meeting packages, FDA correspondences, amendments, and securing product approval.
- To provide regulatory support for product launches and GMP inspections.
- Due diligence and gap analysis of third-party ANDA/NDAs for in-licensing.
Regulatory Affairs – DMF Review | API | US Market Only
- Experience – 04 – 10 Years
- Designation – Senior Executive / Assistant Manager / Deputy Manager
Job Description:
- Candidate should be able to review/prepare API nitrosamine risk assessment reports for global projects. Candidate should be well versed with USA, Canada & EU Nitrosamine guidelines.
- This person will also be involved in CCF evaluation & will maintain nitrosamine status & while papers for global projects.
- Candidate should be able to review/write API DMFs including Peptide DMFs to support complex projects for US, Canada & EU markets. Experience of technical review & module preparation of API DMFs, especially for Peptides. ANDA DS module preparation, review of nitrosamine risk assessment report, CCF evaluation etc. will add value.
- Experience of technical review of API DMFs in terms of synthetic/analytical chemistry like Route of Synthesis, Genotoxicity, method validation reports will add value.
Regulatory Affairs – Labelling (Reviewer) | US & International Market Only
- Experience – 03 – 10 Years
- Designation – Executive / Senior Executive / Assistant Manager / Deputy Manager
Job Description:
- Compilation and/or initial review of labeling documents for OSD & Injectable for original ANDA and Additional strength submission.
- Co-ordinate with CFT for involvement and understanding of priorities and filing timelines.
- Follow-up with respective department to get documents in timely manner and to ensure that all labeling modules are available for submission on time.
- To be updated with current labeling practices and regulatory guidelines.
- Initial review of all deficiency & query responses related to US Labeling for both OSD and Injectable.
- To ensure that all labeling modules are available for CR, IR and DRL submission on time. Co-ordination with cross-functional teams as needed to collect required documents for deficiency responses.
Regulatory Affairs – Clinical | US Market Only
- Experience – 08 – 15 Years
- Designation – Manager / Senior Manager
Job Description:
- Lead the team to assists with all ANDA BE related activities.
- Submission of all ANDA related filings.
- Regulatory archiving and communication tracking.
- Development/management of ANDA roadmaps.
- Tracking recurring regulatory activities.
- Management of department databases and trackers.
- Back & clinical eCTD publishing
Job description:
Analytical Development Injectable | Method Development
Experience – 03 – 07 Years
Designation – Executive / Senior Executive
Job Description:
- Method development like Related compound, Assay, Dissolution and Residual solvents etc. for development projects using instruments like HPLC, IC, GC, Particle size analyzer etc.
- Prepare method development report along with tentative analytical method.
- Attain method transfer activity & Preparation TT report
- Method validation like Dissolution, Assay, Related compound and Residual solvents etc.
- To keep neat and cleanliness at workplace and follow the Good Laboratory Practices in the Laboratory.
- Preparation of study protocols with respect to Laboratory.
- Development batch stability analysis as per stability protocols
- Responsible for COA preparation and release of development sample against TRF.
Formulation & Development – Injectable | Product Development | USA / EU & Domestic Market
Experience – 04 – 10 Years
Designation – Senior Executive / Assistant Manager
Job Description:
- Understanding of product development related activities of all injectable dosage forms for regulated market.
- Exposure to injectable dosage form including exposure in development, scale up and execution of 505 (B2) injectable products, Emulsion, Colloidal solution etc.
- Experienced in preparation and review of product development report, MFR, stability protocol, other study protocols, SOP etc.
- Basic understanding of implementation of QbD principles for formulation development (QTTP, CQA, CPP, CMA, Risk assessment and Control strategy etc.)
- Exposure of various QMS documents like change control, planned deviation, unplanned deviation etc.
- Basic understanding of API specification, DMF, Excipients specification, In-process specification, Finished product & Shelf life specification of injectable products.
- Basic understanding of preparation and review of necessary documents required for ANDA submission and approval of products.
Technology Transfer – Formulation & Development | Injectable
Experience – 03 – 07 Years
Designation – Senior Officer / Executive / Senior Executive
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.
Development QA – Research & Development | Injectable
Experience – 03 – 07 Years
Designation – Senior Officer / Executive / Senior Executive
Job Description:
- Preparation of SOPs and to conduct the Sop Training.
- Induction and Training of new employee and exist procedure completion of employee.
- Coordination with plants and distribution of documents and retrieval documents.
- Receiving, issuance and management of RLD’s.
- To review and approve Stability study protocols and charging and withdrawal of stability samples.
- To Review R&D documents
How to Apply:
- Multiple Job Opportunities in Regulatory Affairs – RA CMC | RA Labelling | RA API | Clinical RA.
- Interested candidate may apply email me your latest cv at kavitriy@amneal.com
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