Senior Manager, Commercial Regulatory - (Remote - US)

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Requirements:

• Bachelor’s degree in a related Life Sciences discipline; Master’s degree preferred.
• Minimum 7+ years of experience in regulatory affairs, specifically in labeling, advertising, promotion, or drug development within the Biotech or Pharmaceutical industry.
• Strong understanding of U.S. labeling requirements and the regulatory process for labeling changes.
• Proven ability to analyze and understand the implications of label changes on pending and approved labels.
• Experience in regulatory affairs with a strong focus on attention to detail and the ability to multitask in a dynamic, fast-paced environment.
• Excellent written and verbal communication skills with a proven ability to collaborate across teams.

Responsibilities:

• Assist in the development of target product profiles, core data sheets, and regional labels.
• Review and approve U.S. promotional materials for assigned assets, ensuring they meet regulatory guidelines.
• Provide regulatory input on promotional concepts and draft materials to ensure alignment with business objectives and regulatory compliance.
• Collaborate effectively with Regulatory Affairs counterparts and cross-functional teams to achieve program goals.
• Maintain professional relationships with internal teams, external partners, regulatory experts, and health authorities.
• Conduct regulatory intelligence research and maintain up-to-date knowledge of regulations.
• Identify regulatory gaps and propose solutions to address challenges.