Manager - Finished Dosage Form(FDF)
Job Description
Job Description Summary
Provides regulatory and operational support for existing third-party customer FDF portfolios across global markets, ensuring compliant maintenance of Marketing Authorizations and timely execution of regulatory changes in line with business and regulatory requirements.Job Description
Position Purpose:
Provides regulatory and operational support for existing third-party customer FDF portfolios across global markets, ensuring compliant maintenance of Marketing Authorizations and timely execution of regulatory changes in line with business and regulatory requirements.
Your Key Responsibilities:
Your responsibilities include, butnotlimited to:
- Manage lifecycle maintenance activities for existing Marketing Authorizations for third-party customer products, ensuring continued regulatory compliance across global markets. Coordinate cross-functional internal stakeholders, including Regulatory Affairs, Quality, Production, and Supply Chain, as well as relevant third-party customer counterparts, to assess regulatory impact and support compliant implementation of changes
- Manage and coordinate maintenance-related regulatory activities with third-party customers to ensure timely and seamless implementation of variations, updates, notifications, and other ongoing business requirements
- Prepare, maintain, and oversee regulatory documentation and records to ensure accuracy, completeness, inspection readiness, and alignment with regulatory standards, data integrity expectations, and internal governance requirements.
- Monitor relevant global and local regulatory requirements and legislative changes affecting existing products, ensuring Marketing Authorizations remain current and compliant
- Provide regulatory, product-related, and compliance-related support within the B2B organization for existing business activities
- Build and maintain effective working relationships with internal and external stakeholders to support aligned and efficient execution of maintenance activities
- Ensure compliance with applicable global quality and regulatory standards, taking into account third-party customer expectations and local market regulatory requirements
- Contribute to resolution of operational issues through structured analysis, coordination, and follow-up with relevant functions. Support continuous improvement of lifecycle management, documentation, and service processes within the Technical Competence Center.
- Key Performance Indicators: Compliance with applicable regulatory and quality requirements. Adherence to agreed regulatory timelines and commitments for existing business activities. Lead time for responding to third-party customer and internal stakeholder requests. Lead time for processing maintenance-related regulatory notifications, submissions, and updates. Quality and completeness of submitted responses, notifications, and regulatory documentation. Number of follow-up clarification requests after submitted responses, notifications, or maintenance activities. Customer satisfaction with regulatory support and coordination for existing business. Delivery of process and service improvements within the area of responsibility. Effectiveness of cross-functional collaboration. Timely and effective regulatory and operational support to the B2B organization. Audit and self-inspection outcomes relevant to the Technical Competence Center. Achievement of individual performance objectives and development goals in line with Sandoz’s performance management framework (Workday)
What you’ll bring to the role:
EssentialRequirements:
- Higher university degree, preferably in Chemistry, Pharmacy, Biotechnology, or another natural science.
- At least 5–8 years of experience in technical, quality, regulatory, or related roles within the pharmaceutical industry. Experience supporting or managing lifecycle maintenance of existing Marketing Authorizations
- Solid understanding of global and local regulatory requirements in a regulated environment.
- Experience coordinating complex cross-functional activities and driving delivery across multiple stakeholders
- Strong communication and stakeholder management skills, ideally including direct customer-facing exposure
- Strong analytical and structured problem-solving skills
- Ability to manage documentation, timelines, and follow-up activities with a high level of accuracy and attention to detail
- Learning agility and adaptability in evolving customer, business, 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 humanrightof good health.
With investments in new development capabilities, production sites, new acquisitions, and partnerships, wehave the opportunity toshape 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 arecommitted to building an outstanding, inclusive work environment and diverseteamsrepresentative of the patients and communities we serve.
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