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Regulatory Affairs Director

1 month ago

Beijing, Beijing, China Bayer Full time

Transforming Healthcare through Regulatory Excellence

About Bayer

Bayer is a global leader in the life sciences, driven by a vision to make a meaningful difference in people's lives. We're a community of innovators, thinkers, and doers, united by a shared passion for solving the world's toughest challenges.

Your Role

As an Associate RA CMC Director, you will play a critical role in shaping our regulatory strategy and ensuring compliance with local regulations. Your expertise will be instrumental in guiding our team to achieve regulatory objectives and drive business growth.

Key Responsibilities

  • Develop and implement regulatory strategies for marketed chemical and bio-products in China, including dossier preparation, QC testing, and CMC review.
  • Mentor junior colleagues and contribute to projects handled by other CMC colleagues.
  • Serve as a primary contact person with Health Authorities for CMC technical review, ensuring timely updates and appropriate actions.
  • Interact with global stakeholders to provide local know-how and form an aligned regulatory strategy.
  • Participate in policy making and provide insights on new regulations and policies.
  • Ensure compliance with Company internal policies, systems, and local regulations.

Requirements

  • Advanced technical degree (Ph.D., D.V.M. or Pharm.D.) in life sciences with 6 years of regulatory experience or MS with 8 years of regulatory experience or BS with 10 years of regulatory experience.
  • Deep knowledge of local regulations and guidance.
  • Familiarity with other agency's regulations and guidance (e.g., FDA, EMA, PMDA).
  • Strong analytical skills and problem-solving abilities.
  • Good communication skills, verbal and written.

What We Offer

Bayer offers a dynamic and inclusive work environment, competitive compensation, and opportunities for growth and development. If you're passionate about regulatory affairs and committed to excellence, we encourage you to apply.