Date PostedAugust 20, 2023
Location (State / UT)
Expiration dateAugust 19, 2024
Experience3 Years, 5 Years
Desired QualificationMaster’s Degree, Bachelor Degree
- Alliance Management & execution of all BD&L deals for EM and EU business, from deal signing to 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
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 & publishing BD&L filing calendar and developing the MIS system for tracking
- Align with CFT – BD&L, RA, QA, PV, packaging, and 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 agencies & 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
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 the LPM team to initiate launch activities
- Support the 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 the forecast
- Work with FPS, finance, and BD teams for timely placement of Launch PO
BD&L Governance, Reporting, and Analytics:
- Prepare and update the 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
- 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
- EM & EU Business head – Regular – review of BD&L deal execution
- IPD, Regulatory – Frequent – 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 – As required – building and finalizing contracts, negotiations, etc.
- FPS – regular – for timely placement of Purchase Orders for Licensed products, liaising with BD&L partners for lead times, etc
- SCM – supply timelines and capacity clearance for IH launches, procurement of high lead time items, managing low-value launches, etc.
- BD&L partners for alignments on filing, approval, and launch timelines
- External regulatory agencies – working with them to compile dossiers for timely submissions, and on query responses during the review period
- Vendors (Auditors, consultants, etc) – need-based – for support on deals, carrying out due diligence
- Manage BD&L filings in EM in a 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 a 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
- BD&L filing plan for EM and EU
- Budget finalization for executed BD&L deals
- Launch plan finalization for FY (IH and IL)
- Process improvement for BD&L deals
Desired Candidate Profile:
Graduate (B. Pharm or B. Engg) and preferably MBA
Relevant Work Experience:
- 3-4 years of experience in business development/portfolio/project management within a pharma company
- Must have strong communication and negotiation skills
- Must have a good hold of MS Excel and be able to undertake data analysis
Job Location: Lower Parel