Director/Sr. Director, Commercial Regulatory Affairs and Labeling

Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults.  Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.

POSITION SUMMARY

Job Functions/Responsibilities

  • Responsible for providing commercial regulatory leadership for assigned programs.
  • Conduct review and approval of commercial labeling and advertising/promotional materials.
  • Serve as regulatory liaison to FDA/CDER/OPDP.
  • Author commercial regulatory submissions and works closely with Publishing vendor to ensure timely publishing and submission of promotional materials to the Office of Prescription
  • Drug Promotion (OPDP).
  • Represent Commercial Regulatory (Advertising and Promotion) at labeling meetings and provide strategic regulatory guidance, as appropriate.
  • Provide regulatory guidance on new concepts and new campaigns.
  • Maintain a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products. Monitor enforcement trends and provide timely advice to the team.
  • Recognized as an expert resource for regulatory advice across departments.
  • May contribute to process improvements relevant to commercial regulatory activities, including the Promotional Review Committee.
  • Develops and implements labeling strategies, including risk assessments, based on understanding of available data on Mirum drug products, regulatory precedence and regional regulatory requirements.
  • Manages the preparation and revision of company core data sheets and regional labeling.
  • Responsible for the development and implementation of regulatory labeling and advertising/promotional processes, as necessary.
  • Build a Commercial regulatory team, scaling with the needs of current and future commercialization activities.

Qualifications

Education/Experience

  • Bachelors or advanced degree in a scientific discipline, with a minimum of 15 years of regulatory experience in the biopharmaceutical industry; minimum of 10 years in Regulatory Affairs with a minimum of 7 years’ experience in the regulatory review of advertising/promotional materials for prescription drug and/or biologic products and at least 3-4 years’ experience leading a Regulatory Labeling function.
  • Experience representing Commercial Regulatory Affairs on cross functional teams is desirable.
  • Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
  • Excellent communication skills both in writing and verbally.Knowledge, Skills and Abilities:
  • Direct experience with FDA’s Office of Prescription Drug Promotion (OPDP) submissions and strategies.
  • Extensive in-depth knowledge of regulatory requirements associated with advertising and promotion of prescription drug products is required.
  • Excellent verbal, written, negotiation, influence and interpersonal communication skills are required.
  • Capable of critically reviewing complex technical/scientific documents and influencing colleagues across functions.
  • Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others.
  • Resilient profile with the ability to deliver in an ambiguous environment.
  • Ability to engage and manage multiple stakeholders to achieve the business objective.
  • Operationally excellent.
  • Organized with systematic approach to prioritization.
  • Process oriented to achieve the business objective.

Work Environment

  • This is a high growth, fast paced small organization. The ability to be productive and successful in a work environment is critical.
  • Some travel required. Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.

To apply, please send your resume to careers@mirumpharma.com.