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Bayer Global Regulatory Affairs Leader in Whippany, New Jersey

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Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life.

At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Apply online

Global Regulatory Affairs Leader

Your tasks and responsibilities

The primary responsibilities of this role, Global Regulatory Affairs Leader, 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 that enable fastest path to first cycle approval;

  • Provides 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;

  • Serves as the 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) and the Biomarker Leader to develop strategy documents to support decision making at Governance committees and for formal meetings with Health Authorities;

  • By leveraging technical expertise relevant to the assigned complex program that has high impact on Oncology portfolio, this position will

  • have serve as the Regulatory Strategy expert on the Global Product Team (GPT);

  • Integrating the local/regional regulatory requirements into the best and single global regulatory strategy requires broad global experience and efficient interaction with many multinational and multifunctional partners;

  • The best global regulatory strategy is important in achieving early approvals with competitive labeling. The assessment on the probability of regulatory success 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 preferred 8 years in medical research activities of which 3-5 years include local/ global regulatory experience in related TA area, or MS degree with 10 years of medical research activities of which 5-7 years include local/global regulatory experience in related TA area, or BS degree with 12+ years of medical research activities of which 10-12 years include local/global regulatory experience in related TA area;

  • Expert knowledge of the regional and global regulations;

  • Demonstrated interactions with local and global health authorities;

  • Excellent communication skills, verbal and written, and strong analytical skills are required;

  • Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence-management skills;

  • A clear understanding of cultural and business needs in leading a diverse team.

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Country:United States


Functional Area:[sapfa32]

Entry Level:5