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Biology Jobs San Diego | Regulatory Affairs Role @ Lilly, San Diego, California-Bachelor’s Degree in biology, pharmacy, nursing, chemistry, or related......

Biology Jobs San Diego | Regulatory Affairs Role @ Lilly

Biology Jobs San Diego | Regulatory Affairs Role @ Lilly, San Diego, California: 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.

Biology Jobs San Diego | Regulatory Affairs Role @ Lilly, San Diego, California

Job Responsibilities:

  • Assist Senior Regulatory scientist in the development of regulatory strategy and update strategy based upon regulatory changes
  • Provide high quality, timely and decisive regulatory advice, which is aligned with the Senior Regulatory Scientist, to allow business partners to make well-informed decisions on development or product lifecycle planning
  • Evaluate regulatory impact on proposed product development plans
  • Understand, investigate and evaluate regulatory history/ background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval
  • Anticipates and resolves key technical or operational issues that have the ability to impact the function or development team.
  • Determine and communicate submission and approval requirements
  • Participate in risk-benefit analysis for regulatory compliance
  • Contribute to the functioning of the crisis/ issue management team.
  • Take a proactive leadership role in the critical review of development strategies for the molecule, seeking Senior Regulatory Scientist and management alignment. Shares regulatory knowledge with team on routine basis to establish trust and credibility
  • Influence others in a manner that creates maximum advantage for the organization.
  • Develop relationships with personnel in other Lilly functional areas (that is, medical, marketing, legal, labeling, compliance, quality and so forth.) to effectively influence the drug development strategies
  • Constructively challenge teams to reach the best solutions to issues
  • Create an environment within their work group or function and across the development team that encourages open discussions on issues to achieve a robust outcome on project decisions
  • Communicates verbally and in writing to effectively influence within work group/function and with development team
  • Communicate with FDA project managers
  • Partner with FDA project managers 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 manneGuide and influence development team and function to create development strategies utilizing emerging science and technologies
  • Partner with the team to provide regulatory guidance during scientific data dissemination, study development, and clinical planning processes
  • Use strong problem-solving skills to address and effectively communicate complex regulatory issues
  • Take a leadership role to ensure the success of our business partnerships

Basic Qualifications:

  • Bachelor’s Degree in Science or health sciences discipline preferred (for example, biology, pharmacy, nursing, chemistry or related scientific discipline)
  • 3- 5 years industry-related experience in regulatory affairs
  • Legally authorized to be employed in the United States.

Additional Skills/Preferences (Biology Jobs San Diego):

  • Knowledge of FDA procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives
  • Knowledge of drug development process, Lilly regulatory/business strategies and plans
  • Experience in Immunology drug development and development of biologics
  • 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 style

Additional Information: 

  • Travel expected (10-15%)

Req ID: 27173
Title: Regulatory Affairs
City: San Diego
State / Province: California
Country: United States

Biology Jobs San Diego | Regulatory Affairs Role @ Lilly, San Diego, California

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.

How to Apply:

View Original Notification and Apply Now

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