Senior Executive / Assistant Manager - Regulatory Affairs - API Amneal Pharmaceuticals

5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

As the Manager of India OSD Pre-approval ANDA portfolio, Injectable Drug Substance pre-approval portfolio, and Global DMF Review portfolio, your primary responsibilities involve providing Drug substance/nitrosamine review support to complex projects, including 505(b)(2), Europe & Canada projects. You will also participate in cross-functional meetings to address regulatory/technical issues and facilitate decision-making processes. Additionally, it is essential to engage with API vendors to gather relevant information and prevent any deficiencies in Drug Substance. Your role also encompasses bridging DMF/API related regulatory decisions between Raks & Amneal Teams, conducting training sessions...

Posted 1 month ago

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Nitrosamine - Senior Analyst Aizant

3.0 - 5.0 years

1 - 5 Lacs

Hyderabad

Work from Office

Dear All, We are looking for Nitrosamine exposure candidates who are having an experience of 3-5 Years into the industry. Responsibilities: Lead method development and validation for trace-level detection of nitrosamines and NDSRIs using advanced instrumentation (GC-MS/MS, LC-MS/MS). Perform root cause analysis and establish robust impurity control strategies based on analytical data and scientific rationale. Prepare and review method validation protocols, risk assessment reports, and regulatory documentation for nitrosamine-related investigations. Interpret analytical data in compliance with GLP, ICH guidelines, and regulatory agency expectations. Drive nitrosamine risk assessments for APIs...

Posted 2 months ago

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General Manager - Extractable & Leachable and Nitrosamine Fusion Scientific Laboratories

15.0 - 24.0 years

25 - 35 Lacs

Navi Mumbai

Work from Office

Job Title: General Manager Analytical Laboratory (Extractables & Leachables and Nitrosamine Impurities) Location: Rabale, Navi Mumbai Company: Fusion Scientific Laboratories Experience: 15+ Years About Fusion Scientific Laboratories: Fusion Scientific Laboratories is a USFDA and EMA-accredited laboratory based in Rabale, Navi Mumbai. We provide specialized services in Formulation Development , Analytical Solutions , and Integrated Pharmaceutical Services to leading pharmaceutical clients worldwide. With a robust focus on regulatory compliance and scientific excellence, Fusion Scientific delivers innovative, high-quality solutions to meet evolving industry needs. Position Overview: We are loo...

Posted 3 months ago

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Research Associate III - Nitrosamine Baxter

12.0 - 18.0 years

18 - 25 Lacs

ahmedabad

Work from Office

Interested candidate can directly mail their resumes at vishwaroop_goswami@baxter.com Research Associate III Nitrosamines (Characterization Team) - Team lead role Baxter Pharmaceuticals R&D is seeking a highly motivated scientist with proven expertise in liquid chromatography and mass spectrometry to join th Characterization team. As a catalyst within the Pharmaceuticals Global Business Unit, the successful candidate will apply state-of-the-art technologies in LC-MS and GC-MS in support of new and existing pharmaceutical products. The associate in this role will support Nitrosamine studies (core), extractables and leachable studies, using mass spectrometry-based approaches to identify nitros...

Posted Date not available

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