Regulatory Affairs Director

2 weeks ago

Beijing, Beijing, China Bayer Full time

Unlock Your Potential at Bayer

About Us

Bayer is a global leader in the life sciences, driven by a vision to make a difference in the world. 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 and collaborating with global stakeholders to achieve business growth.

Key Responsibilities

  • Develop and implement regulatory strategies for marketed chemical and bio-products in China, including dossier preparation and QC testing.
  • 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 CRT, GRT, and Global Regulatory CMC/Global Product Supply to provide local know-how and form aligned regulatory strategies.
  • Participate in policy making via Bayer and industry platforms, providing insights on new regulations and policies.
  • Contribute to tasks such as SOP/OI Taskforce, RA intelligence, and competitor information.
  • 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, guidance, and familiarity with other agency's regulations.
  • Deep knowledge of chemical drug or biological drug development, manufacture, analytical, quality control, GMP, drug therapy, statistical concepts.
  • Awareness of drug development and product maintenance requirements.
  • Good communication skills, verbal and written, and ability to work within a global team framework.
  • Strong analytical skills and demonstrated problem-solving as applied to local regulatory issues.

What We Offer

Bayer offers a dynamic and inclusive work environment, opportunities for growth and development, and a competitive compensation package.

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