Mirum develops patient-inspired therapies for rare disease, advancing medicines where unmet need is greatest. Mirum is relentlessly rare. Learn more. Backed by NEA.
About the role
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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 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
More about this role
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.
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...
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