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Denali Therapeutics Inc
5mo ago

Senior Director, International Regulatory Affairs(m/w/x)

Zürich
Full-timeOn-siteManagement

Description

You will develop and implement regulatory strategies for international products, ensuring compliance and quality in submissions while collaborating with various teams and mentoring regulatory staff.

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Requirements

  • Bachelor’s degree required
  • Advanced degree in life sciences preferred
  • 12+ years of regulatory affairs experience
  • At least 8+ years in international regulatory affairs
  • Direct experience with major international regulatory agencies
  • Success in leading global submissions
  • Developing international regulatory strategies
  • Thorough knowledge of international regulatory frameworks
  • Strong leadership and decision-making skills
  • Project management skills with strategic outcomes
  • Excellent written and verbal communication skills
  • Experience interacting with senior leadership
  • Experience managing and mentoring regulatory professionals
  • Ability to navigate complex regulatory environments
  • High level of professionalism and accountability

Education

Bachelor's degree
OR
Master's degree

Work Experience

12 years

Tasks

  • Develop international regulatory strategies for products.
  • Lead planning and submission of regulatory applications.
  • Serve as liaison with global Health Authorities.
  • Collaborate with teams for clinical trials and registrations.
  • Monitor regulatory developments and assess impacts.
  • Ensure quality and compliance of regulatory submissions.
  • Develop and maintain processes for regulatory activities.
  • Partner with affiliates and consultants for submissions.
  • Support global labeling strategies and alignment.
  • Mentor and manage international regulatory team members.
  • Guide direct reports in goal setting and development.

Languages

EnglishBusiness Fluent

Benefits

Retirement Plans

  • Pension

Additional Allowances

  • Medical stipend

Competitive Pay

  • Equity

Other Benefits

  • Broad range of benefits
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