Senior Executive, Reg Affairs-ARPL-RA AR
3 days ago
About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: . Job Summary Preparation of original DMF, amendments, Annual reports and Review of adequacy of documents for submission Job Responsibilities Compilation, review and submission of various Drug master files for US, EU, TGA, Canada and other markets as per respective regulatory guidelines and checklist Preparation of Original Drug Master File for regulatory submission. Preparation of Amendments and annual reports for regulatory submission. Co-ordinate with technology transfer sites for RA support for DMF and dossiers. Execution of regulatory activities through various tools like, Docubridge, Livelink, RIMS, Trackwise, label bridge etc. Compilation of Deficiency responses for regulatory submission. Review of draft RSM, MPDR and GTI discussion in-line to process and current requirements, and against the screening study data for DMF submission. Change control assessment for regulatory impact before implementation. Risk assessment of DMF’s from various API manufacturing to support in-house ANDA filing. Supporting for Business development related activities (Third party customers) Interacting with supporting departments like R&D, QC, QA, production and AR&D etc. on issues related to RA for DMF submissions and deficiency responses. Administrative and local licensing activities involved in regulatory affairs. All other relevant duties as assigned Job Requirements Education Master’s degree in Science/Pharmacy Knowledge, Skills and Abilities Good command over MS-Office: Word, Power Point, Excel etc. Interacting with supporting departments like R&D, QC, QA, production and AR&D etc. on issues related to RA for DMF submissions and deficiency responses. Experience 6-8 years’ experience in Regulatory Affairs At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
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Reg Affair Officer
2 days ago
Bengaluru, Karnataka, India IQVIA Full timeRole Summary: We are seeking a qualified Regulatory Affairs Project Coordinator and manage outsourced local regulatory affairs activities across multiple international markets. The role involves coordinating regulatory submissions, artwork workflows, database updates, and compliance tracking, ensuring alignment with global standards and internal SOPs. Key...
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Reg Affair Officer
2 weeks ago
Bengaluru, Karnataka, India IQVIA Full time ₹ 9,00,000 - ₹ 12,00,000 per yearRole Summary:We are seeking a qualified Regulatory Affairs Project Coordinator and manage outsourced local regulatory affairs activities across multiple international markets. The role involves coordinating regulatory submissions, artwork workflows, database updates, and compliance tracking, ensuring alignment with global standards and internal SOPs.Key...
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Regulatory Affairs
2 weeks ago
Bengaluru, Karnataka, India MM Staffing & Career Consultants Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Description:Job SummaryThe Regulatory Affairs Manager is responsible for ensuring that products are in compliance with all applicable regulations and laws. This includes developing regulatory strategies, preparing regulatory submissions. The Manager also provides guidance to the cross functional and Area regulatory affairs team and ensures that all...
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Executive - AR / Senior Executive - AR
3 weeks ago
Bengaluru, India Omega Healthcare Management Services Full time🚨 We’re Hiring at Omega Healthcare! 🚨✨ Position / Title: Executive – AR / Senior Executive – AR 📍 Locations: Bangalore & Chennai 🕒 Shift Timing: Night Shift (Mandatory)📅 Notice Period: Immediate joiners / up to 15 days preferred 🔑 Requirements Bangalore: •Strong expertise in Hospital Billing (UB04) •Excellent knowledge of UB04...
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Regulatory Affairs Associate Ii
4 weeks ago
Bengaluru, India Whatjobs IN C2 Full timeRole: Regulatory Affairs Associate II Work location: Mumbai & Bangalore Summary: The Associate II, Complex Gx, Regulatory Affairs is responsible for the preparation and submission of high-quality regulatory filings—both pre- and post-approval—for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex generic products....
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Manager, Quality Assurance-ARPL-QA&C AR
3 days ago
Bengaluru, India Apotex Full timeAbout Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally,...
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QA/RA Specialist
2 weeks ago
Bengaluru, Karnataka, India 3G HR Services Full time ₹ 12,00,000 - ₹ 24,00,000 per yearJob Description:POSITION TITLE: Senior QA/RA SpecialistJOB LOCATION: Bangalore,IndiaDEPARTMENT: Quality & RegulatoryREQUIRED EDUCATION: Bachelor's degree in biomedical engineering discipline or equivalentengineering degreeKEY RESPONSIBILITIES: ➢ Product QA/RA:• Provide quality and regulatory affairs input to the productdevelopment team and handle all QA...
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Regulatory Professional
1 week ago
Bengaluru, India Novo Nordisk Full timeRegulatory Professional **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department: Global Regulatory Affairs** - Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment?...
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Manager, Quality Assurance-ARPL-QA&C AR
10 hours ago
Bengaluru, Karnataka, India Apotex Inc. Full time ₹ 12,00,000 - ₹ 36,00,000 per yearAbout Apotex Inc.Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally,...
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AR & Senior AR Callers
1 week ago
Bengaluru, Salem, India Vee Healthtek Full time ₹ 6,00,000 - ₹ 12,00,000 per yearGreetings from Vee HealthTek...We are hiring for AR Callers & Senior AR CallersExperience: 1 Yrs. to 4 Yrs. ( Relevant AR experience)Process - AR Calling - Denials Management (Voice) / Physician or Hospital billingDesignation: AR Caller/Senior AR CallerLocation - Bengaluru , SalemQualification: PUC and Any graduate can applyOnline interviewsPlease contact HR...
