Associate Director Regulatory Policy

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

Job Description Summary

Join us, the future is ours to shape!

Job Description

Your Key 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.

What you’ll bring to the role:

• Essential Requirements: Minimum 8 years of experience in regulatory affairs, drug development or policy development.
• Health Authority experience is an asset.
• 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.

Please note: This is a temporary fixed term role of 1 year to provide coverage during a period of employee absence.

We also provide flexible working, learning and development opportunities.

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 human right of good health.

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape 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 are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Skills Desired

• Compliance Risk
• Corrective Action Plans (Cap)
• Operational Excellence
• Regulatory Compliance
• Regulatory Reporting

Our Purpose here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible.

Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more!

Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!