Dr. Reddys Laboratories Released Job Openings On 28-01-2022. Dr. Reddy€™s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Application form link provided at the end of post.
Vacancy Details:
Dr. Reddys Laboratories Recruiting M.Sc,M.Pharma with at least 10 years of experience in regulatory affairs comprising minimum of 5-6 years’ experience in submission of parenteral (sterile) productsfor Team Lead- Regulatory Affairs (Parenteral) Position.Complete Details for the Team Lead- Regulatory Affairs (Parenteral) as follows.
Important Details :
- Location : Hyderabad
- No of Vacancies:NA
- Details of Salary: NA
- Opening date for online Application:28-01-2022
- Mode of application :Online
- How To Apply:At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
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Job Description/Skills Required
Review of ANDA/dossiers, deficiency responses, site transfer amendments for US, EU and Canada market (Parenteral/Sterile Products) : Closely work with the team members and review ANDAs/Dossiers, deficiency responses and amendments as per the applicable regulatory guidance’s. Ensure adequacy and completeness of dossier through regulatory guidance’s, ANDA & RTR checklists and templates. Secondary review of critical documents like specifications, MPRs, stability protocols, stability data, QBD document, justification reports
Correspondence with regulatory authorities : Preparation and review of controlled correspondences, Briefing book, Scientific advice meeting packages, Pre-ANDA/ANDS meeting packages, emails, Post CR meeting request etc for parenteral products
Preparing Regulatory strategy notes, regulatory due diligence and gap analysis for leverage products : Evaluating and sharing the RA requirements with product development teams at the product introduction stage, performing regulatory due diligence for in-licensing products and preparing consolidated gap analysis for leverage markets in consultation with vertical head
Timely identifying all open issues : Identify all open issues and anticipated question on regulatory submission at respective stage of product development, ANDA filing and deficiency responses in consultation with vertical head.
Review and closure of change notifications (CRNs) : Review and closure of change notifications in consultation with vertical head for under development, under review and launch products.
Providing regulatory support to commercial launch support: Evaluate launch related documents and facilitate regulatory decisions in consultation with vertical head.
Interact with Internal and External Customers: Interact with Internal Customers (namely Delivery Managers, Project managers, Deficiency Mgt team, Front end regulatory teams etc) and External Customers (namely Co-development/Business partners, Contract manufacturers Regulatory Consultants, etc) and provide timely regulatory guidance on various issues.
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