Job Title

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. About the Role: The Global Program Manager will oversee the drug registration, commercial launch, and life cycle management of the Insulin biosimilars portfolio for the Developed and EM . This role involves managing activities from regulatory strategy, dossier preparation, regulatory filings, query responses, regulatory approval, commercial launch, and post-approval changes, including capacity expansion. The Program Manager will ensure these activities are executed effectively while meeting revenue targets linked to new registrations or commercial launches. The role requires handling multiple projects simultaneously and ensuring strict deadlines are met. The ideal candidate will possess strong analytical skills, a go-getter attitude, leadership abilities, attention to detail, and advanced proficiency in MS Project and Excel. Job Responsibilities: Development & Life Cycle Management of the Insulins Portfolio Programs : Develop & Manage project schedule, Track the execution, budget commitments and spends. Responsible for successful delivery of the projects on-time and within approved budget. Plan & Finalize the Governance Structure and Escalation Matrix for each project Schedule management: Develop project charter, Finalize the Project scope and plan. Track the Plan Vs Actual and report the variance. Pro-actively build scenarios for impact mitigation and minimize delays Monitor the progress through-out the project lifecycle using scheduling tools (MSP, Office timeline) Stakeholder management : Co-ordinate with cross functional teams for the program deliverables. Manage communications, escalation & problem solving to ensure project deliverables stay on track Budget : Plan the program budget (Annual/Quarterly). Budget forecasting for the Development & LCM programs – Liaise with R&D, Regulatory, Clinical & Ops team & finalize the budget forecast for the Fiscal year Finalize, Track and Report the Plan vs Actuals Negotiation with the vendors, CROs for the program related activities. Monitor/control project progression to ensure project is completed on schedule and within budget. Anticipate and provide visibility to internal/external stakeholders for scope/cost creep & revision Regulatory : Ensure data package readiness for dossier submissions. LCM Program: Liaise with RA team and finalize the regulatory pathway for variation filings Liaise with the cross function teams for response submission to the agency queries on time. Facilitate the plan and data readiness for the scientific advice / feedback from regulatory agencies. Legal : Liaise with the Legal team and ensure readiness of CDA, MSA, SOW before engaging with the external vendor and CROs Logistics : Facilitate and track the shipments (project related materials, test items/drugs, testing/biological samples) Procurement : Liaise with procurement team for the availability of project related consumables, equipment’s & other critical reagents required for the program Experience - 7to14 Years.