8 Post Approval Jobs

Position: RAD-US Market, (CMC, M3) Qualification: M. Pharmacy (Pharmaceutics, Regulatory Affairs) Experience: 6-11 yrs Job Location: Hyderabad Job Type: Permanent Responsibilities: Hands on experience with RA-US market ; responsible for Approved and Tentative Approved ANDAs /NDAs [i.e., filing of supplements (CBE, CBE-30, PAS, Response to Queries, Controlled Correspondence, Annual Reports** /Updates etc.,) Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers. Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, an...

Regulatory Affairs Associate Experience: 3-6 years Education: Science Graduate Location: Hyderabad Skills: Regulatory Affairs, EU market, Formulation, RA, European market, Post and Pre approval

Primary Responsibilities: Responsible for finalizing the CMC regulatory strategies for assigned products and provide support to execute tasks independently in accordance with global regulations and guidance procedures. Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. Execute regulatory strategies by leading the development, Review and approval of CMC submission components and documentation to support post-approval supplements, and responses to health authority questions per established business processes and systems. Lead the Change control evaluation, preparation, and sub...

Reporting to Sr. Director - Regulatory Affairs Experience required: 5-8 Years Education: B. Pharm / M. Pharm Department: Regulatory Affairs Key Responsibilities: Prepare the status of all documents related to submission. Compile and review Regulatory submission documents required in line with the relevant guidelines. Coordinate with all stakeholders of the manufacturing plant for the collection of documents. Evaluation of change control: evaluate all post-approval changes. Review of specifications (API, Intermediate, FP, and Shelf life) executed BMRs, BPRs, COA, Method transfer report, Method verification, Analytical chromatograms intended for regulated or non-regulated market submission. Ge...

Opening for - Manager, Regulatory Affairs - CMC@ Mumbai , Pune and Hyderabad location. Experience : 5 to 10 Yrs relevant experience in RA CMC This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies. He would even be responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network ...

Role & responsibilities With moderate to minimal guidance, prepare, review, and compile new submissions, deficiency responses (IRs, DRLs, CRLs), and amendments using the "Right-First Time" approach. Work with their manager to support early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals. Support regulatory assessments and decision-making for significant changes, including site transfers and alternate API sourcing. On occasion, serve as regulatory contact point for cross-functional teams like R&D, QA, Manufacturing & Packaging sites, DMF holders, etc. Monitor and manage regulatory timelines and proactively address data or document gap...

RESPONSIBILITIES Author high- quality CMC documentation for US FDA submissions for Post approval supplements/Annual reports in accordance with latest guidance assuring technical congruency and regulatory compliance. Tracking labeling updates and handle corresponding CBE-0 filing. Provide support in PADER submissions. Review and Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues proactively Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends Co-ordination with stakeholders on a regular basis to extend all technical support required from regulator...

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