Position Title: Associate Director – Regional Regulatory Associate
Job ID: R-93578
Category: Research & Development
Job Type: Full Time, Regular
Location: Bangalore, Karnataka, India
🌍 About Lilly
At Lilly, we unite caring with discovery to make life better for people worldwide. Headquartered in Indianapolis, Indiana, Lilly is a global healthcare leader committed to:
Discovering and delivering life-changing medicines
Improving disease understanding and management
Supporting communities through philanthropy and volunteerism
We put people first and seek individuals dedicated to improving lives globally.
🎯 Role Purpose
The Associate Director – Regional Regulatory Associate provides strategic leadership in regulatory affairs for clinical submissions across the region. The role focuses on:
People management and team development
Ensuring regulatory compliance and execution
Driving effective management of resources, processes, and standards
🧠 Key Responsibilities
1. People Management
Recruit, develop, and retain a diverse and capable workforce.
Ensure robust training plans and timely completion of regulatory competencies.
Support talent identification, career development, and succession planning.
Manage workload based on portfolio prioritization, regional requirements, and expertise levels.
Foster a culture of innovation and inclusivity to ensure diverse perspectives are heard.
2. Regulatory Delivery
Demonstrate business acumen, problem-solving, and learning agility to guide teams.
Manage global cross-functional communication and issue escalation to ensure alignment.
Provide technical leadership on regulatory submissions.
Apply regulatory and process knowledge to drive decision-making.
Develop and monitor metrics for continuous improvement and compliance.
Partner with Quality on process improvements and deviation management.
Optimize capabilities and standardization for clinical regulatory submission processes.
Serve as the primary interface with Quality for deviations, inspections, and audits.
Plan and support submission development for in-licensed, out-licensed, or wholly owned compounds.
Ensure representation in Submission and Approval Expert Network (SAEN).
3. Effective Management
Align resources based on portfolio priorities across business units and geographies.
Maintain a compliance-focused culture and inspection readiness.
Model judgment-based decision-making for regulatory and quality requirements.
Drive continuous improvement and shared learning across processes.
Support strategic initiatives and process optimizations.
Manage external collaboration partners consistently, ensuring alignment with procurement and quality processes.
Actively seek feedback for team performance and implement improvements.
🎓 Qualifications & Experience
Proven experience in regulatory affairs, clinical submissions, or related leadership roles.
Strong people management and team development skills.
Deep understanding of global regulatory requirements and clinical submission processes.
Ability to manage cross-functional teams and complex portfolios.
Excellent communication, leadership, and strategic thinking skills.
Strong problem-solving, compliance, and quality mindset.
♿ Equal Opportunity & Accommodation
Lilly is committed to inclusive workforce practices for individuals with disabilities.
For accommodations during the application process, complete the Accommodation Request Form.
Lilly is an equal opportunity employer, without discrimination based on age, race, color, religion, gender, sexual orientation, gender identity/expression, national origin, disability, veteran status, or other legally protected characteristics.
🔖 #WeAreLilly
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Baton Rouge | Monroe | New Orleans |Washington :
Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
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Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Bavaria |Bavaria :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
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Wuhan |Capital of Netherland :
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Arkansas | Remote Australia |New South Wales :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
Italy |Lombardy :
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Bangkok |Israel :
Netanya | Yavne | Be'Er Sheva | Kfar Saba | Tel Aviv |Remote :
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Rabigh | Najran | King Abdullah Economic City | Jeddah | Riyadh | Khulais |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
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