Title:  General Manager - FRD Non-Orals

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