Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology - Hybrid

Added
28 minutes ago
Type
Full time
Salary
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Related skills

regulatory affairs fda regulatory compliance cfr phrma

📋 Description

  • Proactively captures and disseminates activities of government, industry, and trade associations
  • Maintains awareness of pending changes to communicate impact within Regulatory Operations.
  • Drafts and finalizes comments to regulators and trade associations; communicates proposed policies
  • Represents department and participates in trade associations as needed; develops relationships with
  • Oversee operations productivity and development of regulatory staff for advertising and promotion
  • Develop and guide implementation strategies for promotional activities and ensure training and

🎯 Requirements

  • Bachelor’s degree in science plus 7 years of relevant industry experience; PharmD plus 5 years
  • Experience in US Regulatory Affairs Advertising and Promotion; strong negotiation and communication
  • Experience in management, complex/matrix environments, and cross-functional collaboration.
  • Ability to present information clearly to cross-functional groups and deliver difficult messages
  • Strong knowledge of CFR, FDA guidance, PhRMA guidelines, and cosmetic act is preferred.

🎁 Benefits

  • Medical/dental/vision insurance
  • Paid time off (vacation/holidays/sick)
  • 401(k) retirement plan
  • Participation in long-term incentive programs
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