Team Member – Launch Excellence & Alliance | Cipla | Mumbai

Business Development, International Business, Sales & Marketing
Maharashtra
August 20, 2023
Full Time
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Job Overview

  • Date Posted
    August 20, 2023
  • Location (State / UT)
    Maharashtra
  • Expiration date
    August 19, 2024
  • Experience
    3 Years, 5 Years
  • Gender
    Any
  • Desired Qualification
    Master’s Degree, Bachelor Degree

Job Description

Job Purpose:

  • 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

Key Accountabilities:

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

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

Key Interactions:

Internal:
  • 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.
External:
  • 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

Dimensions:

  • 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

Key Decisions:

Decisions:
  • BD&L filing plan for EM and EU
  • Budget finalization for executed BD&L deals
  • Launch plan finalization for FY (IH and IL)
Recommendations:
  • Process improvement for BD&L deals

Desired Candidate Profile:

Education Qualification:

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

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