Senior Regulatory Affairs Specialist - NPD Clinical Studies

Added
14 minutes ago
Type
Full time
Salary
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Related skills

negotiation regulatory affairs project leadership documentation review regulatory compliance

πŸ“‹ Description

  • Develop regulatory strategies for new product development and market entry
  • Advise cross-functional teams on global compliance requirements
  • Lead regulatory submissions, agency communications and strategy for the US and Canada for complex
  • Provide expert guidance in interpretation of international regulations
  • Represent regulatory affairs team in project meetings
  • Coordinate with OUS global regulatory teams for product registrations and variations

🎯 Requirements

  • 6–8 years of experience in regulatory affairs and bachelor's degree in relevant discipline
  • Agency negotiation and strategic planning proficiency
  • Expertise in global regulatory requirements and registration processes
  • Advanced project leadership and communication skills
  • Technical documentation review and approval capabilities
  • Experience with audits, submissions, and training

🎁 Benefits

  • Market-competitive compensation packages including base pay, incentives, benefits, and equity
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