General Manager

4 weeks ago

Vadodara Gujarat, India Sun Pharmaceutical Industries Full time

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 2 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 3 To provide input to IP team to draft patent strategy 4 Red flagging of issues at the right time Highlighting key issues to the head and management that impacts the program timelines deliverables 5 Responsible for identification mitigation and management of all project related risks 6 Provide periodic progress of projects to the senior management 7 Support manufacturing team for technical issues and provide technical inputs in creation of new facility 8 Represent R D during inspections and audits by various regulatory agencies 9 Execute effective Pre-PIF evaluation to enable PIF approval 10 To identify and propose new product proposals based on unmet need differentiating product 11 Responsible for cost-effective procurements of material instrument equipment 12 To plan implement optimum utilization of manpower resources in all product development activities with cross-functional support 13 To review approve tech-transfer and regulatory filing documents 14 To review innovator procurement quantity and its justification 15 Interact with CMOs Quality Operation Regulatory and other functions for various projects 16 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 17 Represent formulation development in regulatory meetings 18 To ensure that internal quality systems are followed by team 19 To review budget of assigned project To manage project and general budget for product life cycle management 20 To use different applications introduced by management as a part of IT enablement 21 To participate in different management initiatives like PACE Kaizen process excellence and ensure the same for team 22 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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