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Senior Manager API

External
sandoz logoSandoz · Telangana (sandoz)
Full-timeOn-siteToday
AgileComplianceCross-functional CollaborationData AnalysisDocumentationFinancial Analysis
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Health insurance

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Job Description Summary Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! Leads end-to-end product-related regulatory, quality, and technical support services for Active Pharmaceutical Ingredients, ensuring compliant and timely support to internal stakeholders and third-party customers across global markets, while overseeing team delivery, resource planning, and achievement of team objectives. Job Description Major Accountabilities Provide expert guidance on product, quality, regulatory, and compliance matters for APIs, ensuring timely and compliant support for ongoing and new business activities Coordinate cross-functional internal stakeholders, including Regulatory Affairs, Quality, Production, and Supply Chain, as well as relevant third-party customer counterparts, to ensure timely and compliant responses to regulatory authority requirements and customer inquiries Support the development of regulatory strategies for targeted business opportunities in close alignment with Regulatory Affairs Act as the primary technical and regulatory contact for third-party customers, including coordination of audits and site qualification activities Monitor relevant global and local regulatory requirements and legislative changes, ensuring product-related documentation, submissions, and notifications remain current and compliant where applicable undefined Represent the Technical Competence Center across local and global quality, production, and regulatory interfaces across Sandoz and towards external partners Ensure alignment between third-party customer expectations, internal quality standards, and applicable market-specific regulatory requirements Support the definition, implementation, and monitoring of service KPIs, and drive continuous improvement in service delivery and process efficiency Lead, develop, and retain a high-performing team through effective resource planning, onboarding, coaching, capability building, and performance management undefined Contribute to the achievement of group objectives through effective prioritisation, structured reporting, and resolution of complex operational issues Minimum Requirement: At least 13+ years of experience in regulatory, technical, quality, or related roles within the pharmaceutical industry. Solid understanding of API-related regulatory and quality requirements Experience working in complex, cross-functional, and regulated environments Proven people Manager leadership experience, including coaching, development, and performance management Experience leading complex projects and driving outcomes across multiple stakeholders. Strong communication and stakeholder management skills, ideally including direct customer-facing experience Strong analytical and structured problem-solving skills Learning agility and adaptability in evolving business, customer, and regulatory environments Why Sandoz? Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world's medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health. With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported! Join us, help us make healthcare fairer and faster. Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. #Sandoz Skills Desired Agility, Cross-Functional Collaboration, Data Analysis, Employee Development, External Orientation, Finance, Financial Analysis, Healthcare Sector Understanding, Health Economics, Health Policy, Health Technology Assessment (HTA), Innovation, Market Access Strategy, People Management, Pricing Strategy, Public Health, Real World Evidence (RWE), Regulatory Affairs, Reimbursement Strategy, Research Methodologies, Results-Oriented, Statistical Analysis, Strategic Partnerships


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