Regulatory Affairs Executive

**Regulatory Affairs Executive (01 Person)**: **Qualification**: B. Pharm / M. Pharm-RA **Experience**: 2 to 3 Years **Description**: - Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority. - Well versed with the guidelines of ICH and other regulatory. - Preparation of documents for COPP, FSC,...

Company Overview Renown Pharmaceuticals Pvt. Ltd. is a reputable soft gelatin contract manufacturer with a state-of-the-art facility in Vadodara, India. The company upholds the highest quality standards and aims to be a top producer of soft gelatin capsules in India. Renown Pharma is known for its adherence to regulatory standards like MHRA, TGA, and...

Company OverviewRenown Pharmaceuticals Pvt. Ltd. is a reputable soft gelatin contract manufacturer with a state-of-the-art facility in Vadodara, India. The company upholds the highest quality standards and aims to be a top producer of soft gelatin capsules in India. Renown Pharma is known for its adherence to regulatory standards like MHRA, TGA, and WHO-GMP,...

Company OverviewRenown Pharmaceuticals Pvt. Ltd. is a reputable soft gelatin contract manufacturer with a state-of-the-art facility in Vadodara, India. The company upholds the highest quality standards and aims to be a top producer of soft gelatin capsules in India. Renown Pharma is known for its adherence to regulatory standards like MHRA, TGA, and WHO-GMP,...

Job Description: Job Description: Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. ? Preparation, Compilation & Review of Registration documents that include Administrative & Technical. ? Reviewing the technical documents provided by QA, QC,...

Vega Biotec Pvt.Ltd part of Vega group of companies having state of the art manufacturing pharmaceutical formulation factories and having global presence in 25+ countries. We have an opening in the export division. 1. QA/RA executive - Experience - Fresher or 6 months experience Qualification - Msc. chem/ B. Pharma/ M. Pharma Job Profile: 2. Artwork proof...

PR FLEXMAKE PRIVATE LIMITED (P+caRe) is hiring for Quality Control & Regulatory Affairs JOB DESCRIPTIONMaintenance of QM, SOP, Device and Plant Master Files, Quality certification audits, documentation, Manufacturing license for medical devices (Class A&B), Inspecting the final output, model, specifications and design and approving the final productsREQUIRED...

Position : Exe / Sr. Exe (Regulatory Affairs, Baroda) Grade – G12A/G11B Education – B.Pharm / M. Pharm Experience – 4 to 6 years Location – R&D - Baroda Job Description: Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for...

Position : Exe / Sr. Exe (Regulatory Affairs, Baroda) Grade – G12A/G11B Education – B.Pharm / M. Pharm Experience – 4 to 6 years Location – R&D - Baroda Job Description: Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various...

**Title**:Executive**: - Date: Mar 7, 2023- Location: Tandalja - R&D- Company: Sun Pharmaceutical Industries LtdExperience in Analytical Method Development and Characterisation using HPLC, GC, LCMS, GCMS, NMR, DSC, TGA, Raman Spectroscopy and XRD in drug substance and drug products. Experience in analytical method validations in GMP environment. Good...

**Title**:Executive**: - Date: Feb 8, 2023- Location: Tandalja - R&D- Company: Sun Pharmaceutical Industries Ltd**Key Responsibilities**: - Responsible for designing advance workflows to measure & characterize process related impurities at different stages of product development such as Host cell protein (HCPs), Host Cell DNA (HCD) & Leachable. -...

Oversee the planning schedulingand execution of production activities to meet production targetswhile maintaining optimal efficiency and costeffectiveness.Ensure compliance with cGMP(current Good Manufacturing Practices) regulatory requirements andcompany policies andprocedures.Collaborate closelywith crossfunctional teams including Quality Assurance...

JOB DESCRIPTION Designation: Executive/Sr. Executive In process analytics Job Location: Baroda Department: Proteomics Job Objective Searching for highly motivated candidate having technical expertise in Biosimilar product analysis. Key Responsibilities: The candidate is expected to develop HPLC based methods for protein and...

**Work Responsibilities**: - Develop and execute test plans to ensure that all objectives are met. - Implement and monitor test scripts to assess functionality, reliability, performance, and quality of the service or product. - Identify and remedy defects within the production process. - Recommend, implement, and monitor preventative and corrective actions...

Job Responsibilities: To have thorough knowledge and understanding of QC workflows (Analysis/ Review/ Approve/ Investigation etc.), Analytical methods (Instrumental/ Pharmacopoeial chapters/ Monographs), QC instrumentation activities (operation, calibration, preventive maintenance etc.) and Analytical method validation/Method transfer activities and...

Job Responsibilities: To have thorough knowledge and understanding of QC workflows (Analysis/ Review/ Approve/ Investigation etc.), Analytical methods (Instrumental/ Pharmacopoeial chapters/ Monographs), QC instrumentation activities (operation, calibration, preventive maintenance etc.) and Analytical method validation/Method transfer activities and...

**Key Responsibilities**: - Responsible for designing advance workflows to measure & characterize process related impurities at different stages of product development such as Host cell protein (HCPs), Host Cell DNA (HCD) & Leachable. - Responsible for routine in process sample analysis. - Responsible for preparation and review of method development reports...

Job Description 0-1 Year. working experience in Bioanalytical operations as sample processing analyst. Must have excellent skills and knowledge of bioanalytical sample processing techniques. Very good understanding of current bioanalytical guidelines of various regulatory agencies such as USFDA, ANVISA, ICH etc. Development and validation for assay...

**Title**:Executive**: - Date: Mar 31, 2023- Location: Tandalja - R&D- Company: Sun Pharmaceutical Industries LtdExperience in Analytical Method Development and Characterisation using HPLC, GC, LCMS, GCMS, NMR, DSC, TGA, Raman Spectroscopy and XRD in drug substance and drug products. Experience in analytical method validations in GMP environment. Good...

**Title**:Executive**: - Date: Apr 25, 2024- Location: Tandalja - R&D- Company: Sun Pharmaceutical Industries Ltd**Department: F R&D (Non-oral), SPIL, Baroda** **Position: Executive (Replacement of Mr Ankit Soni)** **Requirements**: - M. Pharm in Pharmaceutics from renowned institute (Good Score in GPAT). - Good Academic Career **Responsibilities**: -...