Associate Director Regulatory Policy

Posted 18 Days Ago
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Sandoz, CA, USA
In-Office
Senior level
Biotech • Pharmaceutical
The Role
Develop and advocate evidence-based regulatory policy for generic and biosimilar medicines; align policy and advocacy plans; engage regulators and trade associations; evaluate regulatory impacts; provide strategic regulatory advice, training, and consultation review; represent Sandoz externally.
Summary Generated by Built In

Job Description Summary

Join us, the future is ours to shape!

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.

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.

#Sandoz

Skills Desired

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

Skills Required

  • Minimum 8 years of experience in regulatory affairs, drug development, or policy development
  • Demonstrable multi-year success in regulatory or health policy roles with strong understanding of regulatory and legislative environment
  • Command of the drug development process, pharmaceutical business, and its regulation
  • Experience working cross-functionally and in global teams; organizational awareness
  • Health Authority experience
  • Experience or familiarity with Compliance Risk, Corrective Action Plans (CAPA), Operational Excellence, Regulatory Compliance, Regulatory Reporting

Sandoz Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sandoz and has not been reviewed or approved by Sandoz.

  • Healthcare Strength Health, dental, vision, and prescription coverage are consistently described as core components across U.S. roles and materials. Feedback suggests the medical offering is broad and a standard pillar of the package.
  • Retirement Support A 401(k) plan with a company match described as generous is commonly included for U.S. roles. This savings support is positioned alongside other primary benefits as part of total rewards.
  • Equity Value & Accessibility Equity eligibility is noted for many positions and a global all‑employee share program is being introduced from 2026. These elements add upside beyond base salary and annual bonus.

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The Company
HQ: Basel
17,135 Employees

What We Do

Sandoz is the global leader in generic and biosimilar medicines. ​ ​Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance.​ We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.

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