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11 дней назад

Associate Director, Regulatory Affairs China - Immunology

Формат работы
onsite
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
China
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Associate Director, Regulatory Affairs China - Immunology (Regulatory Affairs/Immunology): Developing and executing China regulatory strategies for immunology assets across development, submission, approval, and lifecycle management with an accent on regulatory pathways, health authority engagement, and cross-functional alignment. Focus on leading CTA, NDA/BLA, supplement, variation, and renewal submissions, resolving complex regulatory issues, and translating evolving China requirements into actionable plans.

Location: Beijing, China

Company

Johnson & Johnson MedTech develops healthcare solutions and medicines designed to prevent, treat, and cure complex diseases.

What you will do

  • Develop and execute end-to-end China regulatory strategies for immunology assets from early development through post-approval lifecycle management.
  • Provide China-specific input to global regulatory strategies, asset development plans, and project decisions.
  • Lead regulatory submissions, including CTA, NDA/BLA, supplements, variations, and renewals, in collaboration with regional, global, and China teams.
  • Develop health authority interaction strategies, lead agency meetings, and coordinate responses to questions and information requests.
  • Assess regulatory risks, create mitigation plans, and resolve complex regulatory issues.
  • Represent China Regulatory Affairs in global and cross-functional teams while coaching junior colleagues and sharing regulatory best practices.

Requirements

  • Bachelor’s degree or above in Pharmacy, Chemistry, Biology, or a related life sciences discipline; an advanced degree is preferred.
  • At least 10 years of regulatory affairs experience in multinational or leading pharmaceutical companies.
  • Strong experience with drug development and registration across multiple products and development stages.
  • In-depth knowledge of China regulatory requirements, guidelines, processes, and health authority expectations.
  • Ability to work effectively in cross-functional and matrix environments, with strong strategic thinking, problem-solving, communication, influencing, and stakeholder management skills.
  • Excellent written and verbal communication skills in both English and Chinese.

Nice to have

  • Therapeutic area experience in immunology.
  • Advanced degree in a relevant life sciences discipline.

Culture & Benefits

  • Inclusive work environment focused on individual dignity, diversity, and employee contribution.
  • Opportunity to work across innovative medicine and MedTech healthcare solutions.
  • Collaboration with China, regional, and global regulatory and business teams.

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