General Manager - FRD Non-Orals

Job Title

Job Grade

Function

Sub-function

Manager’s Job Title

Skip Level Manager’s Title

Function Head Title:

Location:

No. of Direct Reports (if any)

Date Of Joining

Job Summary

Areas of Responsibility

Details Of Responsibilities Assigned

1

• 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

Travel Estimate

Job Scope

Internal Interactions (within the organization)

External Interactions (outside the organization)

Geographical Scope

Financial Accountability (cost/revenue with exclusive authority)

Job Requirements

Educational Qualification

Specific Certification

Skills

Experience