3 Nitrosamine Jobs

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 on regulatory topics, and ensuring the quality and compliance of critical documents/submissions related to DMFs, ANDAs/S, and Amendments. Furthermore, you will be responsible for formulating RA Strategy of ANDA/DMF/DS for ongoing projects, ensuring timely submissions to regulatory authorities, leading the Global DMF Team/Process, and coordinating global regulatory efforts for DMF/API between Raks, Amneal India & Amneal USA teams. Innovation and continuous improvement are key aspects of your responsibilities, as you will be developing RA tools, coordinating with SSSM team/vendors for document requirements, resolving DMF critical issues, and supporting audits with necessary regulatory information. Your role will also involve evaluating critical change notifications, supporting launch activities, handling team management and development, project distribution, resource planning, and candidate selection processes. Additionally, you will conduct yearly performance appraisals, approve team attendance, and ensure compliance with regulatory submissions. The ideal candidate for this role should have an M. Pharm / M. Sc. qualification and possess strong leadership skills, regulatory knowledge, and the ability to drive regulatory compliance across various projects and teams effectively.,

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, excipients and finished dosage forms in collaboration with cross-functional teams. Stay up to date with evolving international regulations and scientific guidance on nitrosamine impurities. Provide technical support during regulatory inspections, audits, and client reviews. Mentor junior analysts and contribute to continuous improvement initiatives in laboratory practices. Note: Interested candidates can share their updated resume to sonyjeevitha.degala@aizant.com

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 looking for a strategic and technically strong General Manager to lead our Analytical Laboratory , with specialized expertise in Extractables & Leachables (E&L) and Nitrosamine Impurities . In addition to managing laboratory operations, this role requires a strong business acumen to drive growth, build client relationships, and expand our service portfolio. The ideal candidate will combine deep scientific expertise with leadership and business development capabilities. Key Responsibilities: 1. Technical and Operational Leadership: Lead and oversee analytical operations related to E&L and nitrosamine impurities. Ensure robust method development, validation, and execution using advanced instrumentation (GC-MS, LC-MS/MS, HRMS). Maintain high scientific standards, ensuring all activities comply with ICH, USFDA, EMA, and other global regulatory requirements. 2. Quality and Compliance Oversight: Ensure all laboratory practices meet GMP, GLP, and data integrity standards. Proactively prepare for regulatory inspections and client audits. Oversee documentation, quality assurance, and submission-ready reporting. 3. Business Development and Client Engagement: Identify new business opportunities in E&L and nitrosamine testing, both domestic and international. Build and nurture strong relationships with existing and prospective clients. Support the commercial team with technical insights during proposal development, client presentations and contract negotiations. Contribute to revenue growth through expansion of service offerings and strategic partnerships. Represent Fusion Scientific at industry conferences, webinars, and networking events. 4. Team Leadership and Development: Lead and mentor a 45 plus high-performing team of scientists and technical staff. Drive a culture of accountability, continuous learning, and scientific excellence. Conduct resource planning, recruitment, and training for analytical functions. 5. Strategic Planning and Innovation: Identify trends, regulatory changes, and technological advancements to evolve laboratory capabilities. Support CAPEX planning for new technologies and equipment to enhance service capacity. Collaborate with cross-functional teams including formulation, regulatory, and quality units to offer integrated solutions. Required Qualifications & Experience: M.Sc. / M.Pharm / Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline. Minimum 15 years of experience in a regulated analytical laboratory, with strong domain knowledge in E&L and nitrosamine impurity testing. Proven ability to lead scientific teams and laboratory operations in a CRO or pharma setting. Strong business acumen and experience in client-facing or business development roles. Familiarity with global regulatory expectations (USFDA, EMA, ICH, etc.). Excellent communication, leadership, and negotiation skills. Why Join Fusion Scientific Laboratories? Work with a USFDA & EMA-accredited laboratory serving top-tier pharmaceutical companies. Be part of a collaborative, innovation-driven culture. Opportunity to lead both technical and commercial growth in a high-impact role. Contribute to advancing global drug safety and regulatory compliance.