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.
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

Skills Required