Senior Regulatory Policy Leader Biosimilars and Generics

NL23 (FCRS = NL023) Sandoz B.V; Almere; On-site; EUR 85,000 - 120,000; Full time

Job summary

Sandoz B.V in the Netherlands seeks an experienced Regulatory Affairs professional to shape policy for generic and biosimilar medicines. You will lead regulatory strategy, interact with Health Authorities, and coordinate industry collaboration.

The role covers developing evidence-based policy positions, advising development teams, and representing Sandoz in trade associations and external groups. This is a 1-year fixed-term assignment with flexible learning opportunities and a diverse, inclusive

Qualifications

• Minimum 8 years of experience in regulatory affairs, drug development or policy development.
• Health Authority experience is an asset.
• Strong understanding of regulatory and legislative environment and drug development processes.

Responsibilities

• Develop regulatory policy positions for regulatory requirements for generic and biosimilar medicines.
• Align policy objectives and advocacy plans within Sandoz and with trade associations.
• Advocate for policy objectives via trade associations, conferences, publications, and regulators.
• Evaluate the impact of regulatory requirements.
• Develop materials and trainings on emerging regulatory requirements for employees.
• Provide strategic regulatory advice to development functions to support health authority meetings, submissions, and lifecycle issues.
• Represent Sandoz at trade associations and external groups.
• Coordinate reviews of Health Authority consultation documents.

Skills

Compliance Risk

Corrective Action Plans

Operational Excellence

Regulatory Compliance

Regulatory Reporting

Job description

Sandoz B.V in the Netherlands seeks an experienced Regulatory Affairs professional to shape policy for generic and biosimilar medicines. You will lead regulatory strategy, interact with Health Authorities, and coordinate industry collaboration.

The role covers developing evidence-based policy positions, advising development teams, and representing Sandoz in trade associations and external groups. This is a 1-year fixed-term assignment with flexible learning opportunities and a diverse, inclusive