Global Regulatory Affairs Director (m/f/d)

Responsibilities

• Participate in or lead departmental and cross-functional task forces and initiatives;
• Demonstrate ability to anticipate risks and responsible for developing solutions to identified risks; understand probabilities of technical success for the solutions;
• Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner;
• Understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects and provide knowledge and expertise to guide team in established and building appropriate regulatory strategy;
• Demonstrate solid understanding of current US and EU regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals.
• Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas and is generally recognized as a resource and leads the department as a subject matter expert for Global Regulatory Affairs.
• Demonstrate increasing independence in the area of regulatory strategy such as understanding broad concepts within Regulatory Affairs and implications across the organization and globally; proactively identify regulatory issues; offer creative solutions and strategies, including risk mitigation strategies;
• Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements;
• Direct the preparation of INDs, CTAs, amendments, briefing documents, and marketing applications (NDAs, MAAs);
• Point-lead for interfacing with Health Authority review teams and is a leader that facilitates approval of regulatory submissions and coordinates responses to Health Authorities with appropriate personnel and departments to resolve new or outstanding regulatory issues;
• Represent company at regulatory agencies for assigned products including planning and conducting meetings as well as ensuring submitted documents are compliant and of the highest quality;
• Work with Regulatory Writing, CMC and Operations teams to establish and meet timelines for regulatory submissions;
• Regularly report to management on progress against objectives and plans. Plan and direct projects and provide technical background, inspiration, leadership, and consultation to cross-functional colleagues as well as members of the global regulatory project team;
• Provides regulatory input to patient-centered outcomes research, market access/HTA strategy and submissions;

Profile

• Master’s degree in a science field such as Biology, Chemistry, or Pharmaceutical sciences
• 10+ years of experience in a pharmaceutical industry in global Regulatory Affairs
• Demonstrated recent successful global Regulatory Affairs track record in the development, submission and registration of new drugs (biologics, innovative medicines, drug/device combination products, etc.) in the US, EU and international countries.
• An extensive background and excellent relationship in working with the FDA,
• Rare disease and pediatric drug development experience is highly desirable.
• Strong working knowledge regarding selection, development and evaluation of Clinical Outcome Assessments (COAs)
• Candidates must have proven strategic development capabilities related to new drug development, commercial support as well as product lifecycle management activities (including relevant interactions with international Business Partners/CROs)
• Regulatory strategic and operational support to implement global Managed Access Programs
• Strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies