Onsite Senior Regulatory Professional

Posted 20 hours ago

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About the role

  • Senior Regulatory Professional managing regulatory submissions for Obesity & Cardiometabolic Health therapies. Driving strategies that impact patients' access to treatment across global markets.

Responsibilities

  • Shape regulatory strategies for Obesity & Cardiometabolic Health therapies
  • Lead end-to-end regulatory submissions to health authorities worldwide
  • Plan and conduct regulatory interactions with health authorities
  • Develop and maintain core labelling
  • Serve as a Regulatory Affairs process expert
  • Mentor junior colleagues and contribute to team development

Requirements

  • PhD, Master's or Bachelor's degree in life sciences
  • 9+ years of relevant regulatory affairs experience
  • 7-9 years of work experience demonstrating solid regulatory affairs qualifiers
  • Proven track record with China, Japan, US and EU submission experience
  • Strong knowledge of regulatory therapeutic areas
  • Demonstrated ability to work independently with high initiative
  • Experience mentoring colleagues
  • Fluent written and spoken English

Benefits

  • Health insurance
  • Retirement plans
  • Paid time off
  • Professional development
  • Opportunities for growth

Job title

Senior Regulatory Professional

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Postgraduate Degree

Location requirements

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