Team Member - Launch Excellence & Alliance

Job Purpose

1. Alliance Management & execution of all BD&L deals for EM and EU business, from deal signing till launch in coordination with BD&L partners
2. Lead BD&L filings in close coordination with BD&L partner, external regulatory agency, Cipla RA & other CFT for timely submissions, approval & launch
3. Support for launch excellence for all New Launches in EM and EU business including in-house & in-licensed launches

Key Accountabilities (1/6)

Manage execution of all BD&L deals across EM and EU for timely submissions and approval

• Coordinate closely with Licensing partners & external regulatory agencies for timely dossier availability meeting country specific filing requirements & publish BD&L filing calendar and develop the MIS system for tracking
• Align with CFT – BD&L, RA, QA, PV, packaging, external regulatory agency to publish the BD&L filing calendar for FY
• Run the governance to track the filing progress across EM and EU along with external regulatory agency & Cipla CFT (RA, QA, PV, packaging, etc.)
• Suggest interventions as required for expediting the filings and approvals
• Participate in & lead monthly / bi-monthly alliance management calls with important partners to review the progress of filing / approval / launches

Key Accountabilities (2/6)

Support in BD&L product launches across all EM and EU markets

• Incorporate the BD&L launches in Rolling Launch Calendar for EM and EU with alignment on timelines with CFT – BD&L, country teams, RA, LPM, SCM, etc.
• Timely project handover to LPM team to initiate launch activities
• Support LPM team, and coordinate with BD&L partner along with Cipla CFT – LPM, RA, QA, and external regulatory agency (as needed) for completion of dossier gap analysis, and necessary pre-launch activities
• Negotiate with BD&L partners on launch timelines, MOQs, critical pre-launch activities, capacity requirements, risk calls in alignment with internal teams, alignment on IP, etc.
• Coordinate with country teams to update the forecast of licensed products periodically, align on drop / continue decision based on forecast
• Work with FPS, finance, BD teams for timely placement of Launch PO

Key Accountabilities (3/6)

BD&L Governance, Reporting, and Analytics

• Prepare and update BD&L deal summary tracker
• Undertake analysis on BD&L deals to assess filing / launches successes as and when needed
• Manage the invoicing process for timely payments to BD&L / external partners
• Support in maintaining the EMEU launch calendar and participate in CFT calls on launches

Key Accountabilities (4/6)

Key Accountabilities (5/6)

Key Accountabilities (6/6)

Major Challenges

• Deal handholding from execution till launch
• Long dossier filing timelines with less visibility into approvals
• Critical CFT alignment – TPQ, RA, PV, LPM, etc for clear roles & responsibilities
• Long launch lead timelines

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