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 Director, Global Regulatory Affairs Advertising and Promotion provides strategic and operational regulatory leadership for all commercial regulatory activities, enabling the business to meet its commercial objectives in a compliant and timely manner. This position will provide leadership as a key member of the Medical, Legal and Regulatory (MLR) and provides experienced regulatory guidance for the preparation, review, approval, and submission of advertising and promotional materials.. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Demonstrated experience reviewing promotional and non-promotional materials in an MLR environment
- Direct experience with the FDA’s Office of Prescription Drug Promotion (OPDP), including promotional material submissions and regulatory strategy
- Experience representing Commercial Regulatory Affairs on cross functional teams is desirable
- Experience with prescription drug labeling, including familiarity with USPI and/or global labeling documents, is preferred
- Excellent planning and organizational skills, with a demonstrated ability to independently manage multiple projects and competing priorities
- Excellent communication skills both in writing and verbally
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 Director, Global Regulatory Affairs Advertising and Promotion provides strategic and operational regulatory leadership for all commercial regulatory activities, enabling the business to meet its commercial objectives in a compliant and timely manner. This position will provide leadership as a key member of the Medical, Legal and Regulatory (MLR) and provides experienced regulatory guidance for the preparation, review, approval, and submission of advertising and promotional materials..
The individual is expected to work with a high degree of independence, accountability, reliability, and follow-through; proactively identify and resolve issues; anticipate risks to timelines or execution; and drive assigned activities to completion with limited day-to-day...
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