CMC Regulatory Expert

1 month ago

Beijing, Beijing, China Novo Nordisk Full time

At Novo Nordisk, we are seeking a CMC Regulatory Expert to join our team. This role will be responsible for regulatory planning and strategy development, including submissions and approvals for CMC issues relevant to new products, license renewals, variations, annual reports, and deregistrations.

Key Responsibilities

  • Develop and implement regulatory plans and strategies to ensure compliance with international and local regulatory requirements.
  • Prepare and submit CMC dossiers and other regulatory documentation to regulatory authorities.
  • Ensure that all CMC-related regulatory submissions are aligned with the company's overall business strategy.
  • Collaborate with cross-functional teams to ensure regulatory compliance and alignment with company policies.
  • Develop and maintain relationships with regulatory authorities and other stakeholders.

Requirements

  • Strong understanding of Chinese regulatory CMC policies and requirements, and familiarity with global regulatory CMC practices.
  • Excellent analytical and problem-solving skills, with ability to handle multiple tasks simultaneously.
  • Good oral and written communication and interpersonal skills.
  • Ability to handle conflicts: initiative and negotiation skills.
  • Fluency in both written and spoken English.
  • Min 6+ years' experience in regulatory CMC.
  • Excellent regulatory CMC related knowledge (regulations, guidelines, intelligence) and experience in CMC of biological and biotechnological products.

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