Associate Director Regulatory Policy

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

Your Key Responsibilities
Your responsibilities include, but not limited to:

• 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.

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.

Your Key Responsibilities
Your responsibilities include, but not limited to:

• 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.

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.

What you’ll bring to the role:

• 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.

#Sandoz