Onsite Regulatory Affairs Specialist

Posted 2 weeks ago

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About the role

  • Regulatory Affairs Specialist responsible for leading regulatory strategies for Novo Nordisk’s Obesity and Diabetes portfolio. Collaborate with cross-functional teams and health authorities for submissions and documentation.

Responsibilities

  • Developing regulatory strategies and lead their execution via interaction with cross-functional teams
  • Leading major submission tracks such as briefing packages for meetings with Health Authorities, clinical trial applications, and global submission strategies
  • Working with affiliates to ensure alignment between local and global regulatory strategies and timely preparation of documentation
  • Reporting to the head of the department and taking active part in department related activities, including improvement projects across RA.

Requirements

  • A Master’s degree or Ph.D. in science, pharmaceutical or health science
  • Minimum 7-8 years of experience in Regulatory Affairs or other relevant area in drug development
  • Practical knowledge in defining and developing global regulatory strategies and good all-around understanding of the regulatory documentation and requirements for pharmaceutical development and licensing
  • Excellent project management skills and ability to cooperate at any organizational level
  • Change-oriented approach and a willingness to experiment
  • Strong communication skills in verbal and written English.

Benefits

  • Health insurance
  • Professional development opportunities

Job title

Regulatory Affairs Specialist

Job type

Experience level

SeniorLead

Salary

Not specified

Degree requirement

Postgraduate Degree

Location requirements

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