Advisor-Global Regulatory Affairs Diabetes

December 19 2017
Life Sciences
Position Type
Full Time
Organization Type
Job Type
The Advisor-Global Regulatory Affairs provides strategic regulatory oversight and is assigned regulatory accountability on individual molecules in development. This is accomplished a strong working knowledge and understanding within regulations, guidelines, and regulatory precedence to expedite the development and delivery of safe and effective products to patients. To accomplish this purpose, it is necessary for the Advisor to develop collegial and mutually productive relationships across Lilly components, partner companies, and within FDA.
  1. Regulatory and Scientific Expertise
    • Provide high quality, timely and decisive regulatory advice that enables business partners to make well-informed decisions on development or product lifecycle planning
    • Communicate the regulatory impact on proposed product development plans
    • Review and approve regulatory strategy documents by leveraging the knowledge from FDA meetings, and regulatory trends. Integrate information from the external environment, product specific regulator advice, and other public information (i.e. Advisory Committees) to develop robust regulatory strategies.
    • Review, identify, and approve key regulatory strategy aspects in external documents such as Dear HCP letters, press releases, and IR communications.
    • Generate regulatory documents for medium to high complexity submissions. Ensure the regulatory document contains appropriate data/information and is written clearly to articulate Lilly position. Approve documents that support the single process map gates and review analysis of how documents relate to regulatory strategy.
    • Pursue a clear understanding of the needs and wants of the regulator and incorporate into regulatory strategies.
    • Execute high quality communications demonstrated through interactions with FDA and internal customers to articulate and ensure understanding of the regulatory strategy and complex issues. Accountable for communications to the regulator, product teams, and GRA management. Assess products risks and effectively communicate the regulatory probability of success to set appropriate internal expectations.
    • May serve as global regulatory coordinator. Must participate in the regulatory coordinator's forum and will share information and regulatory knowledge with others.
    • Monitor upcoming and recent approvals of competitive development programs/plans. Serve as an internal SME for regulatory guidance documents within and outside of business unit focus.
    • Communicate risks regarding right to operate with the development teams and regulatory managementAnticipate and resolve key technical, operational, and strategic issues that have the ability to impact the DCOE function or the development team.
  • Determine and communicate submission and approval requirements
  • May serve as a regulatory technical/strategic leader in a crisis/ issue management team, as needed
  • Actively seeks to deepen regulatory knowledge through constant learning and identifying gaps in expertise
  1. Lead/Influence/Partner
    • Builds, maintains, and leverages relationships with customers (particularly with FDA project managers and supervisory PMs), team members, and partner companies as appropriate. Cultivates relationships with product/platform/PRD leadership.
    • Drives solutions. Is accountable for the regulatory success of high priority and complex molecules in development. Effectively works with partner companies.
    • Identifies and delegates tasks to others on the regulatory team.
    • Serves a regulatory regional leader.
    • Constructively challenge teams to reach the best solutions to issues
    • Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on project decisions
    • Partner with FDA project managers and regulatory reviewers to carefully prepare for and organize meetings, teleconferences and other communications, including requests for advisory comments. Provide required documents, planning details and follow-up notes in a punctual manner.
    • When collaborating with consultants on a project, maintains ultimate regulatory accountability for the regulatory strategy and for the communications with the agency.
    • Demonstrate leadership in ensuring the success of our business partnerships
    • Serve as a mentor for GRA-US personnel and others in GRA
    • Participate in forums that share regulatory information across GRA components

Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Basic Qualifications
  • Advanced scientific degree (i.e. PhD, MD, PharmD) with 7+ years of industry-related experience in regulatory affairs and drug development.
  • OR
  • Bachelors with at least 5 years of relevant drug development experience and 7 years of Industry-related experience in regulatory affairs and drug development experience.
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Additional Skills/Preferences
  • Knowledge of FDA procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives
  • Demonstrated deep knowledge of the drug development process, Lilly regulatory/business strategies and plans
  • Demonstrated ability to assess and manage risk in a highly regulated environment
  • Demonstrated strong written, spoken and presentation communication
  • Demonstrated negotiation and influence skills
  • Demonstrated attention to detail
  • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles

Additional Information
  • Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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