Associate Manager API
Job Description
Job Description Summary
Provides product-related regulatory, quality, and technical support services for API, ensuring timely and compliant coordination with internal stakeholders and third-party customers across global markets.Job Description
Position Purpose:
Provides product-related regulatory, quality, and technical support services for API, ensuring timely and compliant coordination with internal stakeholders and third-party customers across global markets.
Your Key Responsibilities:
Your responsibilities include, butnotlimited to:
· Manage the flow of information and follow-up activities with third-party
customers on API-related quality and regulatory topics and changes, in
close coordination with Regulatory Affairs, Production, and Quality
functions
· Coordinate regulatory and customer-related activities to support timely and
compliant implementation of changes and introduction of new products
· Support Senior Manager API and other relevant stakeholders in handling
complex API-related inquiries requiring product knowledge and structured
analysis. Prepare, maintain, and manage accurate and complete
documentation to address third-party customer requests in support of on
going and new business activities
· Maintain oversight of regulatory and quality-related documentation and
records, ensuring alignment with regulatory standards, data integrity
principles, and internal governance requirements
· Support the handling of customer documentation requests and provide
training to relevant Customer Service team members on Technical
Competence Center procedures where applicable
· Build and maintain effective working relationships with internal and
external stakeholders to support smooth coordination and service delivery
· Ensure compliance with applicable global quality and regulatory standards,
considering third-party customer expectations and local market
requirements
· Contribute to resolution of operational issues through structured analysis,
follow-up, and coordination with relevant functions
· Support continuous improvement of documentation, coordination, 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. Lead time for responding to third-party customer and internal stakeholder requests. Lead time for processing third-party customer regulatory notifications and documentation requests. Quality and completeness of submitted responses, notifications, and supporting documentation. Number of follow-up clarification requests after submitted responses or notifications. Customer satisfaction with regulatory and quality-related support and coordination, 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 commercial organization. Audit and self-inspection outcomes relevant to the Technical Competence Center. Achievement of individual performance objectives and development objectives 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 2–5 years of experience in technical, quality, regulatory, or related roles within the pharmaceutical industry
- Good understanding of API-related regulatory and quality requirements in a regulated environment. Experience working across cross-functional interfaces and coordinating multiple stakeholders
- Strong communication skills, ideally including direct customer-facing exposure. Strong analytical and structured problem-solving skills
- Ability to manage documentation 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
- undefined
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