Regulatory Affairs Manager

Major accountabilities:

• Manages multiple, large and complex local and global regulatory submission projects.
• Develop and provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain local and global products.
• Contribute to strategic and technical input/support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
• A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
• This job is the fully qualified, career-oriented, journey-level position .
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Networks with senior internal and external personnel in own area of expertise.
Contributes to many cost center goals and objectives; may contribute to service line goals -Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)

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What you’ll bring to the role:

• Bachelor’s degree in Pharmacy or related field
• 5+ years of relevant regulatory experience with 2+ years in managerial role within pharmaceutical industry
• Excellent knowledge of local legislation requirements in the field of pharmaceutical registration
• Experience in interacting with government authorities
• Strong knowledge of labeling requirements and GxP documentations
• Attention to detail, organizational skills, and ability to work with documentation
Fluent in English

Work Experience:

• Cross Cultural Experience.
• Managing Crises.
• Functional Breadth.
• Project Management.
• Collaborating across boundaries.
Operations Management and Execution.

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Skills :

• Data Analysis.
• Documentation Management.
• Lifesciences.
• Project Management.
• Regulatory Compliance.
  

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients 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, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Join us!

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.