Global program management - product launch - biologics

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.

• Lead global launch management activities for all Biologics programs for Developed (US, EU, Swiss, CA, Japan) and Emerging markets.
• Liaise with key stakeholders involved in the launch preparation including SCM, Program Management, Commercial, Business Development, Quality, Manufacturing and others
• As a single point of contact for complete ownership of the launch Management; Ensure Artwork development & Procurement, readiness of Commercial BMR to support Drug Substance, Drug Product manufacturing, BPR and DR readiness to support packaging and dispatch of the Finished products across manufacturing sites as per the launch plan
• Liaise with development teams, regulatory and program managers to keep track of post approval variations, in terms of process modifications, reagent changes, site changes, scale changes, as part of life cycle management impacting commercial launch and re-supplies
• Provide regular updates and communications to key stakeholders and management on progress and deliverables
• Draft, publish and track integrated project plans in Microsoft project and or other similar tools
• Identify risk, mitigation paths and ensure timely escalations of events impacting product launch timelines
• Strive continuously to bring in efficiency and improvement in launch management practices to remove bottlenecks and redundancies
• Set up weekly review with Internal and external stakeholders to track, monitor and report the status of the launches across projects
• Participate in joint governance forums (JDC, JCC) to discuss and escalate issues which are impacting commercial launches
• Lead preparation for biweekly calls and monthly reports to Sr. Mgmt and Executive committee

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Behavioral / Management / Other Skills :