Head of Regulatory Affairs

The head of regulatory affairs will be responsible for global regulatory affairs for all drug development programs. This individual contributes to the registration of truly innovative bio-pharmaceutical drugs at a company committed to making a difference in the lives of patients. Provides leadership, develops strategies, and gives operational direction to all regulatory projects with the intent to gain global marketing approval. This is a hands-on position.

Job Duties:

  • Develops the global regulatory strategy for individual programs including preparing the programs for successful registration in all major global markets
  • Defines country-specific regulatory strategies for all programs, assessing optimal route to approval, leading communication and negotiation with global regulatory agencies, and leading the company’s effort in definitive submissions
  • Provides strategic regulatory leadership for all clinical development projects, including but not limited to, overall global regulatory strategy, regulatory requirements for registration in domestic and international markets, and regulatory risk assessments and mitigation for all Company programs
  • Leads communications with regulatory agencies. Prepares briefing and regulatory documents for regulatory agencies, such as Dossiers, NDAs, INDs, and Annual reports. Responds to regulatory agencies with intelligence and diplomacy
  • Ensures that all nonclinical and clinical programs such as pharmacology, toxicology, and clinical trials are appropriately informed and structured to meet US, European, and other regulatory requirements
  • Ensures that all the manufacturing and quality programs relevant to the chemistry, manufacturing and controls of pharmaceutical products, such as process and manufacturing development, validation plans, production, release, and labeling, are appropriately structured to meet US, European, and other regulatory requirements
  • Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through sharing of knowledge, expertise, and relevant information
  • Provides guidance and information to the Senior Management Team on emerging trends, regulations, and health authority guidelines to ensure use of the desired regulatory strategies
  • Provides counsel, training and interpretation of FDA and other regulatory requirements to all Development staff members and where appropriate to other teams and individuals. Cultivates an atmosphere of transparency and problem-solving that encourages requests for advice and input by company staff
  • Interprets and communicates regulatory expectations to internal and external stakeholders (including partners, CROs, CMOs, consultants, and contractors) in order to execute program objectives in compliance with applicable regulations
  • Develops and maintains strong relationships with key stakeholders and regulatory officials
  • Complies with all applicable policies regarding health, safety and environmental policies

Requirements

  • Advanced degree – MD, PharmD, or PhD preferred
  • 15 years of bio-pharmaceutical experience, which include at least 10 years of direct experience in Regulatory Affairs and have successfully filed IND and NDA/MAA submissions
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