Senior Regulatory Policy Lead — Biosimilars & Global Affairs

Sandoz Nederland; Almere; On-site; EUR 90,000 - 120,000; Full time

Job summary

Sandoz Nederland is seeking an experienced Regulatory Affairs professional to develop evidence-based policy positions for regulatory requirements and to align advocacy plans with Health Authorities for generic and biosimilar medicines. You will provide strategic regulatory advice to development functions and represent Sandoz in external working groups.

This position is a temporary fixed-term role for 1 year, offering flexible working and development opportunities within a global biosimilar and

Qualifications

• Minimum 8 years of experience in regulatory affairs, drug development or policy development.
• Demonstrable history of success over multiple years in a regulatory or health policy role with a strong understanding of the regulatory and legislative environment.
• Command of the drug development process, pharmaceutical business, and its regulation.
• Organizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally and in global teams.

Responsibilities

• Developing evidence-based policy positions for regulatory requirements for ethical and efficient development and manufacturing of generic and biosimilar medicines.
• Aligning Sandoz policy objectives and advocacy plans within Sandoz and within the trade association to shape emerging legislative proposals and regulatory guidelines of Health Authorities.
• Advocating for Sandoz policy objectives according to plans, e.g. via trade associations, conference presentations, publications, direct interactions with regulators and other relevant external stakeholders.
• Evaluating the impact of regulatory requirements.
• Developing materials and providing trainings for Sandoz employees on emerging regulatory requirements.
• Providing strategic regulatory advice to development functions to support our pipeline products, e.g. to support Health Authority meetings, regulatory submissions, and life-cycle issues.
• Representing Sandoz at trade associations and external working groups. Provide Sandoz perspectives to those associations and working groups and vice versa.
• Establishing and maintaining network with external stakeholders (policy makers, Health Authorities, industry peers, etc.).
• Coordinating reviews of consultation documents as issued by Health Authorities.

Skills

Regulatory affairs

Job description

Sandoz Nederland is seeking an experienced Regulatory Affairs professional to develop evidence-based policy positions for regulatory requirements and to align advocacy plans with Health Authorities for generic and biosimilar medicines. You will provide strategic regulatory advice to development functions and represent Sandoz in external working groups.

This position is a temporary fixed-term role for 1 year, offering flexible working and development opportunities within a global biosimilar and