YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Global Regulatory Leader, Real World Data, are to: 

• Has accountability for developing robust Global Regulatory Strategy for complex/high impact programs in the Oncology portfolio that leverages accelerated regulatory approval pathways and other innovative strategies including Real World Data that enable fastest path to first cycle approval;
• Provide guidance and oversight to Global Regulatory Strategists on assigned program that have regional and/or local responsibility to ensure integration of regional/local requirements into the overall Global Regulatory Strategy;
• Serve as the Oncology Global Regulatory Expert for the assigned program and partners effectively with the Global Development Leader (GDL)/Early Development Portfolio Lead (EDPL), Global Clinical Leader (GCL)/Early Clinical Leader (ECL), Global Project Leader (GPL)/Early Project Leader (EPL), the Precision Medicine Leader, Real World Evidence Leader and Global Regulatory Policy to develop strategy documents to support decision making at Governance committees and for formal meetings with Health Authorities;
• Leverage regulatory technical expertise to the assigned complex program that has high impact on Oncology portfolio and serve as the Regulatory Strategy expert on the Global Product Team (GPT);
• Serve as the Real World Data Senior Regulatory Expert for the SBU and work collaboratively with other leaders on the Real World Data Taskforce;
• Integrate local/regional regulatory requirements into the best and single global regulatory strategy which requires broad global experience and efficient interaction with many multinational and multifunctional partners;
• Have an effective global regulatory strategy in order to achieve early approvals with competitive labeling;
• Assess the probability of regulatory success, as this has a major impact on the overall Probability of Technical Success (PTS) for a development project and thereby on the prioritization and commercial value of the project.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Advanced technical degree Ph.D., DVM or Pharm.D. in life sciences with at least eight years in medical research activities of which at least three years include local/ global regulatory experience in related TA area OR M.S. degree with 10 years of medical research activities of which at least five years include local/global regulatory experience in related TA area OR B.S. degree with 12 years of medical research activities of which at least 10 years include local/global regulatory experience in related TA area;
• Expert knowledge of the regional and global regulations and real-world data;
• Demonstrated interactions with local and global health authorities;
• Excellent communication skills, verbal and written, and strong analytical skills;
• Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence management skills;
• Clear understanding of cultural and business needs in leading a diverse team.

Preferred Qualifications:

• Minimum of 1 year of Oncology Therapeutic area experience.