MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.

 

 

POSITION SUMMARY

The Associate Director, Global Regulatory Affairs provides management of all aspects of assigned regulatory activities for the dedicated regions and related to the development and commercialization of novel liver drugs including quality, preclinical and clinical areas of drug development. This position will manage the timely delivery of regulatory applications by working with internal stakeholders and with corporate partners and distributors across multiple countries as assigned. The role is responsible for ensuring full regional regulatory compliance, and overseeing submissions and approvals of regulatory procedures including but not limited to IND, NDA, MAA, , and life cycle management activities. 

JOB FUNCTIONS/RESPONSIBILITIES

  • Leads the Regulatory strategy for the assigned projects under the supervision of the Global Regulatory Lead.
  • Leads the Global Regulatory Team Meetings when required by the Global Regulatory Lead.
  • Leads the preparation of regulatory documentation in support of Regulatory Authority Interactions (briefing books).
  • Support the Clinical Operation Team with Clinical Trial Applications.
  • Leads the preparation and the critical review of submission documents to ensure compliance with regulatory requirements.
  • Contributes to and reviews responses to global health authority questions to ensure appropriate, consistent, and complete answers to health authority questions; ensures responses are aligned with global development strategy.
  • Establishes and maintains excellent relationships with international partners and distributors and will be the primary point of contact for partners and distributors as assigned.
  • Provide global regulatory support through the product life cycle by participating in the global project teams (e.g., collaboratively develop international regulatory strategies, timeline development, change control and preparing submission related documents).
  • In collaboration with Regulatory project managers, Regulatory Labelling and Regulatory CMC, oversees the development of content and format for regulatory submissions and related variations and amendments internationally.
  • Actively participates in health authority meetings, when required.
  • Supports the Global Regulatory Lead 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 10 years in the pharmaceutical industry with a minimum of 8 years in Global Regulatory Affairs, experience with major Health Authority (US FDA, Health Canada, and EMA) is mandatory.
  • Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
  • Experience with health authority negotiations.
  • Experience with regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), post marketing measures, Paediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities).
  • Experience in all phases of clinical development is preferred.
  • 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.
  • On site presence at the Headquarter is required (minimum 2 days a week).

#LI-Onsite

Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

Apply for this Job

* Required
resume chosen  
Dropbox Google Drive
(File types: pdf, doc, docx, txt, rtf)
Cancel
cover_letter chosen  
Dropbox Google Drive
(File types: pdf, doc, docx, txt, rtf)
Cancel
When autocomplete results are available use up and down arrows to review
+ Add another education
U.S. Standard Demographic Questions We invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process.
How would you describe your gender identity? (mark all that apply)





How would you describe your racial/ethnic background? (mark all that apply)











How would you describe your sexual orientation? (mark all that apply)








Do you identify as transgender? (select one) (Select one)




Do you have a disability or chronic condition (physical, visual, auditory, cognitive, mental, emotional, or other) that substantially limits one or more of your major life activities, including mobility, communication (seeing, hearing, speaking), and learning? (select one) (Select one)




Are you a veteran or active member of the United States Armed Forces? (select one) (Select one)




Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Mirum Pharmaceuticals’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Enter the verification code sent to to confirm you are not a robot, then submit your application.

This application was flagged as potential bot traffic. To resubmit your application, turn off any VPNs, clear the browser's cache and cookies, or try another browser. If you still can't submit it, contact our support team through the help center.