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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 Director

Maintain 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 Requirements

Review 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 Reporting Timelines (Expedited Reports And Periodic Reports).

AE Follow Up Lilly Process.

Ensure Compliance With Local Regulatory Requirements And Lilly Policies And Procedures Related To Pharmacovigilance, Record Management And Patient Privacy For Both Clinical Trials And Marketed Products.

Coordinate Metrics Compliance And Achieve Metrics Regulatory Tracking Systems

Execute Internal Quality Assessments To The Area To Ensure Compliance Of Local Regulations And Company Policies.

Contribute In The Review And Follow Up On The Procedures Related To Regulatory And Pharmacovigilance Processes And Other Relevant Processes.

Complete All Regulatory And Pharmacovigilance Training Required Locally And Globally.

Collaborate And Help On The Issue Resolution When An Urgent Request Is Received In The Area.

Lead And Coordinate Planning And Execution Of Corrective Actions And Its Implementation Based On The Assessment.

Ensure Execution Of The Action Plan To Prevent Issue Recurrence.

Approve Local Procedures And Quality Documents (Capas, Deviations, Etc.).

Ensure Each Area Member Knows And Understands The Local Regulation And Ensure Its Compliance.

Support Marketing And Other Lilly Areas In The Promotional Material Development

Supervision And Coaching:

Conduct Performance Review With Team Members And Define Key Performance Indicators In Alignment With Company Objectives.

Seek And Act On Opportunities To Enhance Career And Personal Development.

Actively Participate During Identification And Selection Of New Team Members.

Ensure Job Description And Curriculum Maps Are Correctly Assigned To The Team Members And Ensure That An Employee Qualification File For Each Team Member Is Maintained And Up - To Date.

Effectively Lead, Manage, Coach And Mentor The Area Team And Assist Reports In Extending Their Managerial Skills, Technical Skills And Professional Development.

Develop Top Talent.

Minimum Qualification Requirements:

At Least Five Years Of Experience In The Regulatory Affairs Area.

Degree In Chemistry (Qfb, Qbp, Qfi, Iq, Ib, Ibp).

Creativity And Innovation.

Demonstrate Problem Solving And Strategic Thinking.

Team Working Abilities.

Strong Written, Spoken And Presentation Skills..

Good Organization/Self Management Skills And Problem Solving Skills And Initiative.

Good People Management Skills And Ability To Work Proactively.

Effective Communication Skills To Interact With Diverse Groups And Individuals.

Able To Work In Team Environment.

English Language Skills (Fluent Written And Verbal Communications).

Other Information/Additional Preferences:

Act As The Labeling Responsible Person For The Affiliate (Alrp).

Be A Consultant And Expert In Regulatory And Pharmacovigilance Topics For All Internal Clients (Different Areas In The Affiliate).

Participate In Regulatory And Pharmacovigilance Regional Projects.

Participate Actively In External Forums To Drive Changes In Local Regulations.

Participate In The Area Budget Planning And Control

Excellent Communication (Written And Verbal), Interpersonal, Organizational And Negotiation Skills

Travel Or Shift Requirements

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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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