Job Details

Senior Director, Global Regulatory Affairs

Join to apply for the Senior Director, Global Regulatory Affairs role at Mirum Pharmaceuticals, Inc.

Senior Director, Global Regulatory Affairs

1 day ago Be among the first 25 applicants

Join to apply for the Senior Director, Global Regulatory Affairs role at Mirum Pharmaceuticals, Inc.

Get AI-powered advice on this job and more exclusive features.

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.

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 Senior Director, Global Regulatory Affairs will play a significant role in providing regulatory strategic leadership on multiple clinical development programs associated with rare diseases in assigned Therapeutic Area (TA). This role will represent the regulatory function and provide guidance to Program Teams across the organization which include Clinical Development, Clinical Operations, Biometrics, Nonclinical Science, Drug Safety and Pharmacovigilance, and Quality Assurance for assigned projects. This role will be the Global Regulatory TA Lead, responsible for ensuring global regulatory compliance and overseeing timely delivery of submissions and approvals of regulatory procedures including but not limited to IND, NDA, MAA, and life cycle management activities for multiple projects.

Job Functions/Responsibilities

• Develops and oversees the global regulatory strategy for projects in assigned TA, in conjunction with and under the leadership of the SVP, Global Regulatory Affairs.
• Leads the Global Regulatory Project Team meetings in collaboration with Regulatory Project Management when being the Global Regulatory Lead on a project.
• Oversees the preparation of regulatory documentation (meeting request/briefing books) in support of interactions with a Health Authority and provide guidance to their team.
• Oversees/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 responses, ensuring their alignment with global development strategy.
• Provide global regulatory advice through the product life cycle by representing the regulatory function in the Program Team when being the Global Regulatory Lead on a project.
• In partnership with Regulatory Project Management, Regulatory Labelling and Regulatory CMC, oversees the development of content and format for regulatory submissions and related variations/amendments internationally in assigned TA.
• Actively participates in Health Authority meetings.
• Clearly articulate regulatory challenges/risks, identify potential solutions, and make a recommendation(s) on a path forward to Program Teams and Senior Management.
• Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating regulatory changes to Program Teams.
• Effectively manages direct report(s) and provide mentorship to junior professionals.
  
  

• 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 15 years in the pharmaceutical industry with a minimum of 12 years in Global Regulatory Affairs, experience with major Health Authorities (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 major regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), Paediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities) is highly preferred.
• Experience in all phases of development and post marketing activities is highly preferred.
• Demonstrated ability to analyze and interpret efficacy and safety data.
• Strong understanding of regulatory operational activities.
• Outstanding people management skills are required.
• Outstanding interpersonal and communication skills.
• Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on the regulatory strategy for a given product is required.
• Demonstrated proficiency in organizational awareness, including experience working cross-functionally representing the Regulatory Affairs function and on global teams.
• Excellent planning and organizational skills and ability to work simultaneously on multiple projects with tight timelines.
• Supports the SVP, Global Regulatory Affairs as required.
  
  

• This is a high-growth, fast-paced small organization. The ability to be productive and a team player is critical.
• Ability to work under minimal supervision.
• 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).
  
  

The salary range for this position is $270,000 to $285,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Mirum Pharmaceuticals, Inc. by 2x

Get notified about new Director Global Regulatory Affairs jobs in Foster City, CA

Mountain View, CA $192,000.00-$270,000.00 1 week ago

San Francisco Bay Area $340,000.00-$390,000.00 2 weeks ago

Director, Competition, Regulatory, and Antitrust Legal

San Mateo, CA $271,300.00-$406,900.00 2 weeks ago

San Francisco Bay Area $166,360.00-$234,864.00 2 weeks ago

Director, Regulatory Affairs - Job ID: DRA

Associate Director, Transactions Counsel

Pleasanton, CA $232,400.00-$314,400.00 14 hours ago

South San Francisco, CA $235,000.00-$275,000.00 1 day ago

Sr. Director, Corporate Affairs & Legal Leadership Communications

Foster City, CA $243,100.00-$314,600.00 1 week ago

San Francisco, CA $166,360.00-$234,864.00 2 weeks ago

Director, Assistant General Counsel - Procurement

Vice President / Head of Regulatory Affairs

Redwood City, CA $306,000.00-$350,000.00 2 weeks ago

Palo Alto, CA $220,000.00-$250,000.00 2 weeks ago

Director, Contracts and Transactions Counsel (SSF, CA)

Senior Director, Associate General Counsel-Head of Patent Litigation

Director, Assistant General Counsel - Procurement

Dublin, CA $239,000.00-$357,000.00 1 week ago

Senior Director, Associate General Counsel - Head of Patent Litigation

San Francisco, CA $300,000.00-$400,000.00 3 weeks ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

J-18808-Ljbffr