Job Description
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
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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
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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