Associate Director/Director, CMC Regulatory Affairs

Mirum focuses on finding and developing drugs for difficult to treat liver diseases.  Our lead program is focused on two severe liver diseases in children, Alagille Syndrome and progressive familial intrahepatic cholestasis (PFIC).  Both conditions can result in severe itching, liver damage and a need for liver transplant.  Based on a wealth of data from clinical trials spanning multiple years and involving more than one hundred patients, we believe our approach can address the underlying cause of symptoms and liver damage.  Our goal is to give families their lives back.

POSITION SUMMARY:

The Associate Director/Director, CMC Regulatory Affairs is a newly created position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the effectiveness of the Regulatory Affairs team. The position will be responsible for all CMC-related submission planning and for ensuring that high‑quality and accurate submission documents within agreed upon timelines. The ideal candidate will need to be able to accurately interpret and discuss data within cross-functional teams and with health authorities.

PRIMARY RESPONSIBILITIES:

  • Leads the development and implementation of all CMC regulatory strategy to support global development programs and market applications for our programs.
  • Responsible for ensuring the appropriate execution of CMC regulatory strategy.
  • Actively seeks out knowledge of overall corporate planning and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge into submission planning.
  • Ensures the effectiveness of the CMC Regulatory team in developing submissions and in working across functions.
  • Serves as a subject matter expert in CMC Regulatory Affairs for API and drug product manufacturing, global submissions, etc.
  • Lead the preparation of risk assessments on CMC regulatory topics.
  • Builds and manages relationships through active partnering with key internal and external stakeholders.
  • Ensure CMC dossiers meet ICH format and content requirements, as well as specific local requirements of individual countries.
  • Analyze and exercise judgment on complex issues, guided by a thorough understanding of CMC.
  • Support regulatory submission (NDA, MAA, etc), briefing books (BB), response documents for health authority interactions and address questions/requests, as well as an annual update (e.g. IB).

QUALIFICATIONS:

  • Minimum 10 years of relevant experience in Regulatory Affairs CMC.
  • Experience in drug development, market applications and commercial lifecycle.
  • Bachelor’s degree in a relevant scientific discipline, advanced degree preferred.
  • Must have experience with small molecule regulatory CMC (not biologics).
  • Combo product experience/knowledge preferred.
  • Demonstrated track record of successful submissions to FDA and/or other health authorities, including EMA.
  • Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
  • Excellent interpersonal, verbal and written communication skills as well as the ability to effectively lead and influence others are essential in this collaborative work environment.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

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 5-10% of work time.

Please submit your resume to careers@mirumpharma.com

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