Senior Regulatory Affairs Analyst - Americas | PwD Affirmative Position

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Position Summary

Support the local regulatory strategy and plan for assigned product(s) in country, ensure local plan aligns to the global regulatory strategy and ensure local regulations and region/country business needs are included.

Responsibilities

• Collaborate with the implementation of the regulatory plan in collaboration with GRA functions and affiliate cross-functions in alignment with affiliate business plans as well as regulatory requirements.
• Ensure submission and approval of high-quality regulatory applications within planned timelines. Maintain or support maintenance of clear metrics for Regulatory deliverables.
  • Preparation and support of new applications to obtain marketing authorizations.
  • Present affiliate’s perspectives and needs to global and regional regulatory contacts.
  • Ensuring timely responses to requests from support groups and/or Regulatory Authorities.
  • Maintaining marketing authorizations (timely submission of post approval maintenance activities like renewals, variations and periodic reports)
  • Effective collaboration with GRA Regional Regulatory Team supporting submission operational tasks to ensure high efficiencies of submission operations including planning process management, regulatory tools management, dossier preparation and product maintenance.
• Maintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment. Communicate changes to appropriate management and cross-functional experts as appropriate and implement locally.
• Develop the regulatory plan.
• Actively participate in the affiliate launch teams, anticipating and delivering regulatory outcomes to support the affiliate launch plan.
• Represent the Regulatory Affairs function in Affiliate Lead Team / New Product Planning discussions.
• Interact directly, or facilitate interactions with, regulatory bodies with effective communication and negotiation ensuring impactful influence.
• Voicing affiliate needs and perspectives to global and regional regulatory contacts.
• Lead regulatory audits and inspections in collaboration with Regulatory Quality Organization.
• Ensure that all products comply with local regulations and quality system requirements whichever is more stringent.
• Identify local process improvement opportunities and ensure implementation of relevant global regulatory initiatives.

Minimum Qualification Requirements:

• Bachelor’s degree in Pharmacy
• Knowledge of local/regional regulatory procedures and practices, and drug development process
• Effective teamwork, communication and negotiation to establish positive networking and influence internally and externally
• Demonstrated good information technology skills
• Fluency of written and spoken English and local language.

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Lilly 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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