Manager/Sr. Manager- Regulatory Affairs
17 hours ago
- Responsible for regulatory activity related to clinical section for US, ;EU, WHO, Canada, Australia, New Zealand and South Africa Markets
- Preparation of bioequivalence related sections of ANDA product dossiers as per current regulatory guidelines
- Ensure timely preparation of amendments related to bioequivalence to expedite approvals
- Review of BE protocol for all market including ROW market
- Review of bio-waiver information and clinical strategy before start of clinical study.
- Confirmation of reference product for EU countries for clinical study
- Review and Preparation of 2.4 (non-clinical review) and 2.5 (clinical review) module for EU submissions
- Review of SmPC, PIL, Labeling for US, EU and other markets with reference product to keep the generic product labeling up to date.
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Navi Mumbai, Maharashtra, India, Maharashtra Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
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Navi Mumbai, Maharashtra, India, Maharashtra Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
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Regulatory Affairs
1 week ago
Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 5,00,000 - ₹ 15,00,000 per yearPosition: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).Experience- 1-5 YearsJOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This...
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Regulatory Affairs Specialist
1 week ago
Mumbai, Maharashtra, India Easebiz Fintech Solutions Full time ₹ 15,00,000 - ₹ 25,00,000 per yearOne of our client based at Mumbai (Reputed MNC Company) is looking for below positionsRole & responsibilities1. Asst Manager / Manager/Sr. Manager - Biologics Regulatory Affairs (Clinical Trials)-2 positionsJob Location: Govandi (East ), Mumbai (alternate Saturday working)Desired Qualification: M.Pharm/B.PharmDesired Work Experience: 5-10 yearsJob...
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Manager-Biologics Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India USV PRIVATE LIMITED Full time ₹ 6,00,000 - ₹ 18,00,000 per yearYou will be working as an Asst Manager / Manager in the Biologics function of USV Private Limited in the Regulatory Affairs department specifically focusing on Clinical Trials for the EU and US markets. Your role will involve the following key responsibilities: - Developing Biosimilar Clinical Development Strategy, focusing on clinical trials and injectables...
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Regulatory Affairs Specialist
1 week ago
Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 5,00,000 - ₹ 12,00,000 per yearPosition:Sr. Executive / Asst. Manager / Deputy Manager – Regulatory Affairs (Domestic)Location:Andheri, MumbaiQualification:M. Pharm. (Experienced preferred)Job Description – Regulatory Affairs (Domestic)The role requires strong expertise in theDrugs & Cosmetics Act and Rules,FSSAI regulations, andFDA-related activities. The profile will ensuretimely...
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Assistant Manager-Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India Baader Schulz Laboratories Pvt. Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per yearWe are seeking a detail-oriented and proactive Assistant Manager for Regulatory Affairs to join our team. The role involves preparing, reviewing and submitting regulatory documents aligned with Dossier preparation for CIS, Asian and African countries. The ideal candidate should have a strong knowledge of regulatory frameworks and experience in the...
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Regulatory Affairs Executive
1 week ago
Mumbai, Maharashtra, India Talent Sutra Full time ₹ 15,00,000 - ₹ 25,00,000 per yearDesignation:Regulatory affairs -Executive/ Sr. ExecutiveJob Location:MumbaiJob Summary:The primary responsibility for the position is to oversee the daily activities of the Regulatory Affairs. Ensure that deliverables are being met based on planned submission timelines. Directs the development of submission of Product registration Dossiers, amendments, PSUR...
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Manager - PLCM (Regulatory Affairs)
6 days ago
Mumbai, Maharashtra, India Apotex Full timeAbout Apotex Inc.Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the...
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Regulatory Affairs Specialist
1 week ago
Mumbai, Maharashtra, India Tek Support Full time ₹ 1,04,000 - ₹ 1,30,878 per yearJob Title:Regulatory Affairs Specialist Med/Pharma (Female)Location:RemotePosition Overview:We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring...