Director, International Regulatory Affairs

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

The Director, International Regulatory Affairs provides leadership pertaining to all aspects of regulatory affairs related to the development and commercialization of novel liver drugs including quality, preclinical and clinical areas of drug development. The Director will develop policies/procedures required to ensure compliance with regulations internationally (ex-US and ex-EU). This position will develop regulatory strategies and timely delivery of marketing applications across multiple countries with optimal product labelling in regional markets (in collaboration with the Senior Director, Regulatory Commercial and Labeling). The role is responsible for building and maintaining excellent working relationships with competent Health Authorities (HAs) internationally, ensuring full regional regulatory compliance, and overseeing submissions and approvals of dossiers.  This leader will work cross-functionally to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate, accounting for the complex interplay between International Health Agencies

JOB FUNCTIONS/RESPONSIBILITIES

  • In collaboration with Regulatory project leads and Regulatory CMC, designs strategic vision for the Regulatory Affairs function internationally and ensures its successful execution by the respective project teams.
  • Represents Regulatory on the commercial and development project teams (as needed).
  • Conduct risks and gaps assessment and identifies potential areas of regulatory concern and responds to new government/regulatory developments.
  • Advises project teams regarding the development and implementation of regulatory strategy through the CMC, clinical and nonclinical development processes globally across multiple regions outside of the US and EU.
  • Establishes and maintains excellent relationships with global health agencies (ex-US and ex-EU) and will be the primary point of contact for these Agencies on the company’s filings.
  • Shapes regulatory environment by active participation at HA meetings, when required.
  • Contributes to and reviews responses to HA questions with a primary focus on preclinical and clinical aspects to ensure appropriate, consistent, and complete answers to HA questions; ensures responses are aligned with global development strategy.
  • In collaboration with Regulatory project leads and Regulatory CMC, sets strategic direction on the development of content, format, and accountability for regulatory submissions and related variations and amendments internationally.
  • In collaboration with Regulatory project leads and Regulatory CMC, sets strategic direction on the development of content, format, and accountability for regulatory submissions and related variations and amendments internationally.
  • Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to project teams.
  • Supervise the development and implementation of regulatory strategies for the remainder of the ex-US and ex-EU countries.
  • Supports and ensures that the generation of ex-US and ex-EU product information is aligned with global strategy.
  • Responsible for effective and compliant International label translation processes.
  • Works effectively with clinical, market access, medical, pharmacovigilance, quality, and commercial functions in the international organization.
  • Supports the Head of Regulatory Affairs as required.

QUALIFICATIONS

  • Bachelor’s or Master’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent); An advanced degree is desirable.
  • A minimum of 12 years in the pharmaceutical industry with a minimum of 9 years in international Regulatory Affairs.
  • Experience with building and/or leading the Regulatory functions in International Affiliates.
  • Fluency in English as a business language; additional language is an asset.
  • Significant experience in a leadership role with MAA submissions and approvals.
  • Experience in a leadership role with HA negotiations in multiple regions outside of the US and EU.
  • Experience with brand optimization strategies and commercial awareness.
  • Demonstrated ability to analyze and interpret efficacy and safety data.
  • Strong understanding of regulatory operational activities.
  • Outstanding management, interpersonal, communication, negotiation and problem-solving skills.
  • Demonstrated proficiency in organizational awareness, including experience working cross-functionally and on global teams.

Work Environment:

  • This is a high-growth, fast-paced small organization. The ability to be productive and successful in a work environment is critical.
  • Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 10-15% of work time.

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