Team Member

1 week ago


Lower Parel Mumbai Maharashtra, India Cipla Full time

**Division**:

- Emerging Markets and Europe**Department**:

- Planning**Sub Department 1**:
**Job Purpose**:

- Alliance Management & execution of all BD&L deals for EM and EU business, from deal signing till launch in coordination with BD&L partners
- Lead BD&L filings in close coordination with BD&L partner, external regulatory agency, Cipla RA & other CFT for timely submissions, approval & launch
- 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 'œ 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 'œ 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 'œ 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 'œ TPQ, RA, PV, LPM, etc for clear roles & responsibilities
- Long launch lead timelines

**Key Interactions (1/2)**:
**Internal**
- EM & EU Business head 'œ Regular 'œ review of BD&L deal execution
- IPD, Regulatory 'œ Frequent 'œ for dossier compilations, regulatory query resolutions.
- QA for timely site audits, dossier review & PAF / NPI finalization, timely Gap Analysis, change control review & approvals, etc.
- Other CFTs like PV for finalizing PV agreements, IP for alignment on date enabled launches, Packaging team for support needed in dossier submissions, etc.
- Legal and Finance teams 'œ As required 'œ building and finalizing contracts, negotiations etc.
- FPS 'œ regular 'œ for timely placement of Purchase Orders for Licensed products, liaising with BD&L partners for lead times, etc
- SCM 'œ supply timelines and capacity clearance for IH launches, procurement of high lead time items, managing low value launches, etc.

**Key Interactions (2/2)**:
**External**
- BD&L partners for alignments on filing, approval, and launch timelines
- External regulatory agencies 'œ working with them to compile dossiers for timely submissions, and on query responses during review period
- Vendors (Auditors, consultants etc) 'œ need-based 'œ for support on deals, carrying out due diligence

**Dimensions (1/2)**:

- **Manage BD&L filings in EM in year**: ~35-40 dossiers (15-20 product-country) submissions in FY with ~18-20 Mn year 3 revenue potential
- **Manage BD&L filings in EU in year**: ~10-15 product-country submissions with ~10-12 Mn year 3 revenue potential
- **New Launches**: Support on time launches across EM and EU with revenue potential of ~12-15 Mn in a fiscal

**Dimensions (2/2)**:
**Key Decisions (1/2)**:
**Decisions**
- BD&L filing plan for EM and EU
- Budget finalisation for executed BD&L deals
- Launch plan finalisation for FY (IH and IL)

**Key Decisions (2/2)**:
**Recommendations**
- Process improvement for BD&L deals

**Education Qualification**:
Graduate (B. Pharm or B. Engg) and preferably MBA

**Relevant Wor


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