Reg Aff

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 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.The Purpose Of The Regulatory & Patient Safety Associate Director Is To Lead The Regulatory Affairs And Patient Safety (Ps) Department To Ensure The Registration Of New Chemical Entities, Line Extensions And New Indications In Alignment With The Affiliate Business Plan, While Maintaining Compliance For All Marketed Products With Local And Corporate Regulatory And Ps Requirements, Foster An Environment Of Operational Excellence Through Deep Regulatory And Ps Expertise, Managing And Developing Direct Reports, External Focus And Achieving Or Exceeding All Local And Corporate Business Objectives.Primary Responsibilities: This Job Description Is Intended To Provide A General Overview Of The Job Requirements At The Time It Was Prepared. The Job Requirements Of Any Position May Change Over Time And May Include Additional Responsibilities Not Specifically Described In The Job Description. Consult With Your Supervision Regarding Your Actual Job Responsibilities And Any Related Duties That May Be Required For The Position.**Strategy**:Discuss And Align Regulatory / Patient Safety (Ps) Strategy And Objectives With Affiliate Medical DirectorMaintain A Pharmacovigilance System To Support Patient Safety And Ensure Safety Profiles Of Lilly Marketed Products Are Monitored And Communicated, As Appropriate.Ensure Alignment And Implementation Of The Region And/Or Other Area/ Corporate Regulatory And Ps Initiatives.Evaluate Impact And Establish Area Strategy For Updates Or New Releases On Local Regulations.External Relationship With Authorities, Industry Associations And Other Key Regulatory Partners.Develop And Implement A Regulatory External Influence Program To Maintain Relationships With Key Regulatory Officials And To Influence Regulators To Achieve Positive Outcomes.Gather Relevant Information From Local And Global Regulatory Environment With Potential Local Impact Or For Our Competitive Advantage.Build Strong Networks In The Lilly Global Regulatory Affairs And Ps Organizations.Provide Input Into Affiliate Strategic Initiatives As Required.Supervise That The Area Strategy Is Executed With Quality And On The Established Timelines.Oversee The Budget For The Area.**Area Plan**:Oversee Key Product Registration Strategies For Products In The Affiliate Portfolio Based On Overall Area Strategy.Ensure Issues And Gaps Are Identified And Communicated To The Upper Management And Other Areas In The Affiliate As Necessary.Direct The Activities Of The Area To Ensure The Submission And Approval Of Quality Applications Within Planned Affiliate Timelines.**Submissions**:Oversee Product Dossiers Are Submitted Within Planned Affiliate Timelines And Regulatory Approvals Are Obtained For New Chemical Entities, Line Extensions And New Indications To Meet The Affiliate’S Launch Plans And Regulatory RequirementsReview With The Medical Team The Medical Dossiers Information That Needs To Be Translated For The Products That Are Going To Be Submitted.Implementation Of Risk Management Plans (Rmp) Involving Collaboration And Communication With The Business Functions And Affiliate Involved With The Designs And Implementation Of Risk Minimization Activities And Post-Marketing Safety Surveillance.Oversee Advertisements, Investigational Protocols, Import Licenses, Good Manufacturing Practices (Gmp), Free Sales Certificates (Fsc), Selling Approvals Are Submitted.Respond To Regulatory Agency (Ies) Questions Within Or Before The Due Date, As Determined By The Regulatory Agency And Regulatory Metrics.Act As An Expert Consultant In The Regulatory Topics For Internal Customers And Other Lilly Affiliates.Support Regulatory Activities And Revisions In The Manufacturing Site (Packaging Activities).Establish And Maintain Good Working Relationships With The Global Regulatory Team To Ensure Timely Availability Of Regulatory Support.Ensure That The Medical Team Is Adequately Trained In The Required Tasks Related With The Submission Of The Product’S Dossiers.**Compliance**:Supervise That The Adverse Events (Ae) And Other Safety Information Received From Any Source (Lilly Employee, Sales Representatives, Consumers, Clinical Trials, Health Care Providers, Patient Support Programs, Marketing Regulatory Affairs, Alliances, Literature, Etc.), Is Promptly Reviewed And Reported To The Regulatory Agency As Needed Following The Local Procedure And In Compliance With Regulatory Report