General Manager

3 weeks ago

Vadodara India SUN PHARMA Full time

Job Description Job Title Group Lead FRD Non-Orals Job Grade G7 Function Formulation R&D Sub-function FRD Non-Orals Manager's Job Title Vice President- FRD Non-Orals Skip Level Manager's Title Function Head Title: Vice President- FRD Non-Orals Location: R&D Vadodara No. of Direct Reports (if any) 6 Date Of Joining Job Summary Group Lead FRD Non-Orals Areas of Responsibility Details Of Responsibilities Assigned 1 . To define, manage product development milestones and timelines. - Lead team through technical support for end to end development activities enabling ANDA, NDA and IND based product development for US, OAM, EM & India market. - To provide input to IP team to draft patent strategy. - Red flagging of issues at the right time. Highlighting key issues to the head and management that impacts the program timelines/deliverables. - Responsible for identification, mitigation and management of all project related risks. - Provide periodic progress of projects to the senior management. - Support manufacturing team for technical issues and provide technical inputs in creation of new facility. - Represent R&D during inspections and audits by various regulatory agencies. - Execute effective Pre-PIF evaluation to enable PIF approval. - To identify and propose new product proposals based on unmet need, differentiating product. - Responsible for cost-effective procurements of material, instrument & equipment. - To plan & implement optimum utilization of manpower & resources in all product development activities with cross-functional support. - To review/approve tech-transfer and regulatory filing documents. - To review innovator procurement quantity and its justification. - Interact with CMOs, Quality, Operation, Regulatory, and other functions for various projects. - Liaise with the clinical and regulatory CRO on various development issues prior to study and filing and review throughout the process of the study and submissions as needed. - Represent formulation development in regulatory meetings - To ensure that internal quality systems are followed by team. - To review budget of assigned project. To manage project and general budget for product life cycle management. - To use different applications introduced by management as a part of IT enablement. - To participate in different management initiatives like PACE, Kaizen & process excellence and ensure the same for team. - To ensure team capability developments/up skilling to enable robust and quality products development for regulated markets. Key Skills Deep Technical Knowledge Innovation Management Stakeholder Management Regulatory Compliance Cross-functional Collaboration Risk Assessment Travel Estimate Yes, to multiple Non Orals sites Job Scope Internal Interactions (within the organization) ADD, FRD, MSTG, MFG External Interactions (outside the organization) Vendors & CMOs, CROs Geographical Scope Global Financial Accountability (cost/revenue with exclusive authority) Job Requirements Educational Qualification M. Pharm / PhD Specific Certification Skills Experience 20+ Years

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