General Manager
2 days ago
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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Manager - Biotechnology
2 days ago
Tandalja, India SUN PHARMA Full timeJob Title: Manager – Biotechnology UPS Business Unit: R&D1 Regulatory Affairs Job Grade G10 Location Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you...
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MANAGER - Biotechnology
2 days ago
Tandalja, India SUN PHARMA Full timeJob Title: Manager - Biotechnology Business Unit: R&D1 Regulatory Affairs Job Grade G10 Location Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter...
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Manager MSTG
2 days ago
Tandalja, India SUN PHARMA Full timeJob Title: Manager – MSTG NOSD Business Unit: R&D1 Regulatory Affairs Job Classification Code: New Function: R&D Grade : G10 Location Central India (Greenfield Project) Key Responsibilities At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and...
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Manager -2
2 days ago
Tandalja, India SUN PHARMA Full timeJob Title: IT- Manager(Trackwise) Job Grade (refer to JE) G10A Function: IT Location: Tandalja(Baroda) Areas Of Responsibility At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own...
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Senior Manager
2 days ago
Tandalja, India SUN PHARMA Full time1. Characterization of RLD pack samples. 2. Finalization of packing configuration for Exhibit batch packing of new generic product/NDA as per requirement. 3. Identification of new packaging material & new vendor development for packaging materials. 4. Mold development for primary packaging material & secondary packaging material & its validation. 5. Support...
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Manager 2 - Regulatory & Business Continuity
2 days ago
Tandalja, India SUN PHARMA Full timeJob Title: Manager – Regulatory & Business Continuity Business Unit: R&D1 Regulatory Affairs Job Grade G11A Location Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own...
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Manager -2 MSTG
2 days ago
Tandalja, India SUN PHARMA Full timeJob Title: Manager 2 – MSTG Non Orals Business Unit: R&D1 Regulatory Affairs Job Grade G11A Location : Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you...
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Senior Executive/ Manager 2
2 days ago
Tandalja, India SUN PHARMA Full timeJob Title: Senior Executive / Manager 2 – Analytical Development (LCMS) Business Unit: R&D1 Regulatory Affairs Job Grade G11B/G11A Location : Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You...
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Manager 2- Formulation Development Non Orals
2 days ago
Tandalja, India SUN PHARMA Full timeJob Title: Manager-2 - FR&D Non-Orals (Compliance group) Business Unit: R&D1 Regulatory Affairs Job Grade G11A Location : Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own...
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Tandalja, India SUN PHARMA Full timeJob Title: Manager Global Quality Sustainability, Training and Quality Culture Business Unit: Global Quality & Compliance Job Grade G10 Location : Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You...
