Amneal Pharmaceuticals is hiring For Regulatory Affairs.Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. Together, our team is working to build one of the most dynamic pharmaceutical companies in our rapidly changing industry.
Vacancy Details :
- Company Name: Amneal Pharmaceuticals
- Location : Ahmedabad
- Post Name: Regulatory Affairs
- Qualification: B.Pharm,M.Pharm
- Experience: 3 to 8 Years
- No of Vacancies: Not Disclosed by Recruiter
- Details of Salary: 2,00,000 – 7,00,000 P.A.
- Contact: firstname.lastname@example.org
- Mode of application : Online
- Selection Process: interview
Job Description/Skills Required :
Looking for candidates exclusively handling MDP DPI Products at analytical front with hands on experience in development, Validation and routine stability.
Desired Job Profile :
Amneal is looking for Regulatory Affairs-US Market professionals at Ahmedabad.
Department: Regulatory Affairs (Injectable/Sterile)-US Market
Designation: Executive/Senior Executive and Manager
Function: Regulatory Affairs-Pre Approval
Experience Required: 3-12 Years
- Experience of ANDA and FDA query response submission for Injectable, Ophthalmic, Otic, and Complex Injectable Products.
- Review of documents with respect to compliance to regulatory guidelines and submission requirements for Injectable, Ophthalmic, Otic, and Complex Injectable Products within timeline.
- Review of technical documents received from R&D, ARD, QA, QC, Production and CROs for ANDA submissions.
- Preparation and submission of quality dossier as per regulatory requirements within timeline.
- Primary review of API DMFs and follow up with concerned team to get all required documentation.
- Basic literature search and preparation of White Papers for Ophthalmic and Otic Products projects.
- Preparation of cover letter and sections for Amendments and Critical Supplements.
- Co-ordination with R&D, ARD, QC, QA, Clinical, Labeling team for completion of assigned technical and regulatory task.
- Review of labeling for all assigned projects.
Department: Regulatory Affairs (OSD)-US Market
Function: Regulatory Affairs-Post Approval
Experience Required: 9-12 Years
- Extensive knowledge of ANDA submission activities and post approval
- API DMF review with respect to USFDA regulatory requirement.
- Thorough knowledge of solid oral dosage form and manufacturing process
- Ability to assess the change cases with respect to post approval USFDA
- guidance Knowledge of Post approval submission guideline and procedure for
- Annual report/CBE 0/CBE 30 and PAS filling
- Compilation of the Annual Report and ensuring its submission as per stipulated
- Ensure the no delay in submission always keen to adopt first to file approach.
- Ensure better management of major supplements submissions.
- High quality review of entire submission package to avoid any major
- Maintain regulatory information as per current department practice.
- Coordination with Cross Functional teams for the documents availability.
Department: Regulatory Affairs (e-CTD Publishing)-US Market
Function: e-CTD Publishing
Experience Required: 2-5 Years
- CTD/e-CTD compilation, publishing, validation for US and EU Submissions.
- QC Check of PDF Files as per internal Regulatory Operations MaPP.
- Update the eCTD tracking sheet after uploading the documents.
- Archival and life cycle management of the e-CTD submission.
- Priority Management. Understand criticality of any given tasks and discuss any identified issues with RO Group Lead.
- Submission level publishing of PDF file like Uploading to eCTDXpress,
- External linking, Compilation, Validation and Submission to ESG Gateway.
- PDF Document check as per PDF specification required for US FDA requirements.
- Quality work for all assigned publishing and review task by Group lead.
- Well aware about the possible FDA eCTD related deficiency and focusing on preventing them with goal of no eCTD deficiency in every submission project.
- Co-ordinate with RA CMC project manager for submission data and their timely submission to Agency.
- Active involvement in all the group activities and support to team member for routine work to accomplish the targeted submission.
Department: Regulatory Affairs (Labelling)-US Market
Designation: Executive/Senior Executive
Experience Required: 2-5 Years
- Labeling part of Original ANDAs and Amendments (DRL/IR/CR).
- Labeling Supplements: To prepare and review below labeling components and RLD word documents; Amneal Redline; and Labeling SBS (side-by-side) of Package insert and carton/container labeling.
- Revise Structure Product Labeling (SPL) to ensure FPL (Final Printed Label) is available for submission.
- To ensure current version of Container/Carton/Blister label is available for Ok-to-print activity.
- To ensure that labeling modules are available for submission.
- Preparation and review of labeling component of site transfer projects [i.e. word file, Redline, Clean file, Structured Product Labeling (SPL)].
- To ensure availability of all artwork (FPL, container, carton and blister label) and review the same.
- Initiate change controls as and when required for labeling changes.
- To prepare and review Cover Letter and 365h form for all supplements.
- Proof reading of soft copy, hard copy, transparency, shade cards and first print of all labeling components.
- To compile and review annual reportable change received from the agency in supplement approval letter and all Annual Reportable changes are submit in next Annual Report cycle.
Interested Candidate can share their cv to email@example.com