DESCRIPTION

Responsible for independently leading and coordinating the global compilation and worldwide submission of dossiers for new chemical and biological marketing authorization applications, complex life cycle dossiers, original INDs, and the related health authority responses based on regulatory strategies. Independently act as an expert in process development, eSubmission-specific requirements and the development of regulatory strategies for unique situations. Perform submission planning and other submission preparation activities on behalf of RA product manager. Responsibility also includes independent governance for U.S., Regional and local OPUs in the Americas.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

REQUIREMENTS

• Masters degree in scientific/technical discipline from an accredited institution, with five-plus (5+) years of related industry experience; Or
• Bachelors degree in scientific/technical discipline from an accredited institution, with eight-plus (8+) years of related industry experience; Or
• Associates degree in scientific/technical discipline from an accredited institution, with ten-plus (10+) years of related industry experience:
• A minimum twelve (12) years of pharmaceutical industry experience.
• Experience with preparation of marketing authorization applications, Original INDs, or complex regulatory submissions to health authorities.
• Expert skills in the Submission Management areas of document management, submission planning and compilation.
• Possess a deeper technical understanding of related systems in order to address and resolve technical issues as needed.
• Demonstrated leadership skills.
• Strong communication and interpersonal skills.
• Must be detail-oriented, well organized with excellent planning, project management and decision-making skills.
• Must be able to handle multiple priorities and act independently.
• Demonstrated ability to develop collaborative partnerships with individuals they do not supervise.
• Excellent ability to manage conflicts and negotiate difficult situations
• Demonstrated flexibility and adaptability.
• Must be able to quickly adapt to and accept a changing environment and be willing to take on any task required to provide support to the Global Regulatory Operations organization.
• Demonstrated learning agility.
• Must be able to learn and use new systems/tools, methodologies and processes, while not jeopardizing quality.
• Must take responsibility and ownership for timely decisions, actions/non-action and results.
• Must support execution of quality management principles and requirements.
• Demonstrated understanding of FDA and ICH requirements and guidances related to Submission Management activities.