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Senior Manager – Commercial Regulatory
| Company | Travere Therapeutics |
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| Location | San Diego, CA, USA |
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| Salary | $128000 – $165000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- Bachelor’s degree in related Life Sciences discipline
- Master’s degree preferred
- Minimum 7+ years of regulatory and/or related experience (e.g., labeling, ad promo, drug development, medical writing, etc.) within the Biotech or Pharmaceutical industry
- Knowledge and understanding of pharmaceutical drug development and regulations pertaining to labeling, specifically, US labeling requirements and guidance
- Demonstrated ability to understand implications of label changes on pending and approved labels
Responsibilities
- Assist cross-functional teams in development of target product profile, core data sheet, and regional labels
- Review and approval of US promotional materials for assigned assets
- Provide promotional regulatory input on concepts and draft materials to help ensure promotional materials are consistent with regulatory guidelines and support business objectives
- Collaborate to achieve team, department, and corporate goals across programs
- Liaise effectively with Regulatory Affairs counterparts to ensure aligned representation and decision making
- Ensure effective and professional relationships with internal teams, external scientific and business partners, regulatory experts, and health authorities
- Ensure applicable regulatory requirements are considered and appropriately incorporated into all programs, ensuring compliance with appropriate regulations and guidelines
- Assist in Regulatory Intelligence in research and analyze regulatory information and maintain current regulatory knowledge
- Identify gaps and challenges and propose options to address them
- Apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions.
Preferred Qualifications
- The ideal candidate will embody Travere’s core values: courage, community spirit, patient focus, and teamwork
- This position requires academic scientific training, analytical skills, and keen attention to detail
- Strong professional experience in a similar role within the pharmaceutical industry
- Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment. Ability to perform job duties with minimal oversight
- Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complex projects and interdependent timelines
- Strong interpersonal and organizational skills and excellent verbal and written communication skills are required
- Ability to adapt to evolving project timelines and goals, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
