Senior Executive - Launch Readiness & Execution Management
Job Title: Senior Executive – Launch Excellence Europe
Location: Hyderabad
Industry: Pharmaceuticals
Experience: 5-8 years
Job Summary: You will act as the Project Control Room for all new product launches in the UK and European markets. Based at our Hyderabad office, you will be the central point of contact and an active driver of the process. Your mission is to ensure that every department, from manufacturing in India to the Quality teams in Europe are perfectly synchronized for a flawless Day-1 Launch.
Key Responsibilities:
Stage 1: Pre-Launch Setup & Compliance
- Market Strategy: Confirm the final Go decision from corporate launch management team and obtain sales forecasts from the UK & EU Commercial teams.
- SAP Setup: Ensure the SAP team creates all necessary SKU codes in SAP and sales orders are punched to initiate the manufacturing process.
- Clearance: Work closely with Portfolio team to obtain formal clearance for launch who will liaise with Legal and Regulatory on patent expiry timelines for Day 1 launch and ensure we have 100% compliance to operate.
- Regulatory Green Light: Verify that the European Regulatory team has all approvals in place so manufacturing can begin.
- PV Readiness: Work with the European Pharmacovigilance team to ensure all drug safety monitoring systems, reporting channels and EU-specific PV requirements are active and ready before prior to launch
- Launch Tracking: You will maintain a comprehensive Launch Tracker Sheet, ensuring that all project data, timelines and status updates are accurate and available at a single click for the CFT and leadership team.
Stage 2: Manufacturing & Quality in India
- Production Planning: Work with the Demand planning and Manufacturing team in India to finalize BMR/BPR and schedule the production run.
- Material Readiness: Track the availability of API, raw materials and packaging components with the Procurement and in-house API teams.
- Site Release: Coordinate with the India QC/QA teams to ensure the product is tested and officially released from the factory on time.
Stage 3: International Logistics & Documentation
- Freight Management: Align with India Logistics and European Commercial teams on the best shipping mode (Air vs. Sea) and get necessary freight cost approvals from Finance and commercial teams.
- Export Paperwork: Ensure availability of all essential dispatch documents including Invoices, Packing Lists, CoA and CoC/BRCs.
- Warehouse Readiness: Confirm that the European 3PLs and transporters are ready to receive, scan and shelf the incoming stock.
Stage 4: European Quality & Market Entry
- Lab Readiness (AMT): Before the product even arrives in Europe, you must ensure the Analytical Method Transfer is successfully completed. You'll coordinate between the India R&D/QC teams and the European testing labs to make sure the lab is validated and ready to test the launch batches immediately.
- Lab Testing & Sampling: Coordinate with the EU Quality and Supply Chain teams to ensure lab sampling plans are ready and that samples reach the testing labs immediately upon arrival.
- Document Transfer: Manage the flow of manufacturing records (BMR/BPR) and test results from India to the European Quality teams.
- The Final Step (QP Release): Facilitate the final Qualified Person (QP) release in the UK and EU. You are responsible for ensuring the QP has every document needed to sign off so the product can be sold on Day 1.
Stage 5: Post launch management (6-9 months)
- Supply Continuity: Monitor the post launch supply to ensure there is no stock-out after the initial launch quantities are sold. You will track the next 2-3 replenishment cycles closely.
- Performance Review: Lead Post-Launch Reviews to identify any hiccups in the supply chain or quality release process and fix them for future launches.
- Handover to Business as Usual (BAU): Once the product is stable (typically after 6 months), manage the formal handover of the product's supply chain management to the routine SCM operations team.
Other responsibilities
- Weekly Alignment: In addition to above core responsibilities, you will lead or participate in weekly launch meetings to provide status updates, align on next steps and keep all stakeholders synchronized on the countdown.
Who We Are Looking For
- Experience: 5-8 years in Pharma Supply Chain or Project Management, specifically handling European market launches from an India-based hub.
- Knowledge: Deep understanding of EU-GMP, QP release process and Indian export logistics.
- Tools: Proficiency in SAP, Microsoft Excel and Project Management tools is a significant advantage.
- Mindset: A proactive, hands-on candidate who can influence teams across different time zones and take full ownership of the launch date.
