Sandeep S. Badgujar
Ambernath
Summary
Dynamic senior manager with a proven track record at Alivira Animal Health Limited, excelling in sales pipeline development and customer relationship management. Expert in regulatory compliance and project management, successfully driving market research initiatives and fostering strong client partnerships. Adept at delivering innovative solutions that enhance customer satisfaction and operational efficiency.
Overview
19
19
years of professional experience
Work History
Senior Manager - BD, Sales and Marketing, Techno Commercial, Operations and Projects
Alivira animal health limited
Thane
08.2022 - Current
- Identifying and qualifying potential customers through various channels, developing and maintaining a sales pipeline.
- Engaging with prospective and existing customers to understand their requirements, and presenting products and services to customers.
- Key account manager for the SEA, ANZ, and MENA markets. Handling major customers in the EU, US, and LATAM markets.
- Having a valid visa for the U.S. and E.U.
- Managed events like CPHI Worldwide.
- Managing key accounts and ensuring high levels of customer satisfaction, handling customer complaints, and resolving issues promptly.
- Conducting market research to understand customer needs and market trends, and developing comprehensive marketing strategies and plans.
- Identifying new business opportunities and trends, analyzing competitor activities, and market positioning.
- Building and maintaining strong relationships with existing and potential clients, understanding client needs, and tailoring solutions to meet those needs.
- Acting as the single point of contact between clients and internal teams, such as R&D, Supply Chain, Regulatory & Quality, Projects, etc.
- Working with internal stakeholders to ensure on-time, in-full, at-quality delivery to clients, tracking progress on delivery to clients, and reporting status updates, risks, and bottlenecks to senior management.
- Customer query handling and providing the best possible solutions on technical, regulatory and commercial points.
- HANDLING and MANAGING the CDMO and NPD projects with innovator.
Manager - Regulatory Affair API
NGL Fine chem Limited
Andheri
11.2021 - 08.2022
- Heading the department, coordinating all the RA activities beginning from development stage till filing
- Selection of KSM, justifying impurities, Query handling/responding
- Reviewing the documents for the correctness
- Change control reviews from filing point of view
- Preparing customer change notifications for changes
- Managing overall filing profile across the globe
- Defining Regulatory strategy for new API's
- NDC generation and Submission
- Hands on experience of CESP, ESG submissions.
Assistant Manager - Techno commercial API
Alivira Animal Limited
Thane
07.2019 - 11.2021
- Acting as the single point of contact between clients and internal teams such as R&D, Supply Chain, Regulatory & Quality, Projects, etc.
- Working with internal stakeholders to ensure On Time, In Full, At Quality delivery to clients Tracking of progress on delivery to client and report status updates, risks and bottlenecks to senior management.
- Customer query handling and providing the best possible solutions on technical, regulatory and commercial points.
- HANDLING and MANAGING the CDMO and NPD projects with innovator.
- Handling end to end activities for new projects starting from introducing the organization till the starting of commercial supplies.
- Co-ordinating directly with clients for the fastracking and completion of projects.
Assistant Manager - Regulatory Affair API
USV Private Limited
Govandi
07.2018 - 06.2019
- Electronics submissions of Dossiers, X forms for FDA, GDUFA Fees.
- E-CTD softwares Xtido, EDUCE.
- Labeller code, Importer registration
- NDC generation and Submission
- Hands on experience of CESP, ESG submissions.
Sr. Executive - Regulatory Affairs
Alivira Animal Health Limited
Thane
08.2016 - 06.2018
- Giving Regulatory clearance for R & D department coordination for new product development as per ICH guidelines.
- Compilation and submission of the Drug Master Files/ Active Substance Master File in eCTD format for product registration in different countries.
- Compilation and Submission of Amendment/Variation and Annual report for various Regulatory Authorities such as USFDA, EDQM and also for Health authorities of EU countries (National Procedure), Taiwan FDA, Health Canada, Middle East countries (Kuwait, Jordan, Iraq, Qatar, Bahrain), Singapore, Brazil etc.
Regulatory Affair Executive
Unique Chemicals (A division of J. B. Chemicals and pharmaceuticals Ltd.)
Panoli
09.2015 - 07.2016
- Compilation and submission of the Drug Master Files/ Active Substance Master File in eCTD format for product registration in different countries.
- Compilation and Submission of Amendment/Variation and Annual report for various Regulatory Authorities such as USFDA, EDQM and also for Health authorities of EU countries (National Procedure), Taiwan FDA, Health Canada, Middle East countries (Kuwait, Jordan, Iraq, Qatar, Bahrain), Singapore, Brazil etc.
Quality Assurance Manager and Regulatory Affair Manager
M/s Danashmand Organic Pvt. Ltd.
Mumbai
07.2012 - 03.2015
- Preparation & Submission of DMF in eCTD format to regulatory authorities like EDQM, USFDA, etc.
- Preparing quality control plan and approval from client.
- Accountable for getting Approval from Regulatory Authorities & Clients.
- Planning and Execution of work scope to meet the project deadline.
- Review, specification with planning and schedule.
- Involve in Audit clearance affairs by exacting clients.
- Dealing with all implemented standard like c-GMP, GLP and Regulatory requirements with their specifications and codes.
HOD (Anatomy, Physiology and Pathophysiology Dept)
V.M.H.P. shah College of Pharmacy
Thane
06.2009 - 06.2012
Laboratories Griffon Pvt. Ltd. (Franco Indian Pharmaceuticals)
Mumbai
08.2006 - 05.2007
- Planning of manufacturing and packing operations as per GMP.
- Completion of daily production.
- Ensure that materials are labeled properly and used in right quantities.
- Investigate issues, analyze root causes and define resolutions.
- Preparation of daily men worksheet.
Education
HOD - Anatomy, Physiology and Pathophysiology Dept
V.M.H.P. shah College of Pharmacy
Thane, India06.2012
Masters of Pharmacy -
Skills
- Sales pipeline development
- Market research
- Regulatory compliance
- Project management
- Technical documentation
- Customer relationship management
Training
- Visited CPHI India 2018 - 2023
- Exhibited CPhI Frankfurt 2022
- Exhibited CPhI Barcelona 2023
Languages
- English
- Hindi
- Marathi
Personal Information
- Passport Number: H 4376511
- Date of Birth: 03/07/84
- Nationality: Indian
- Marital Status: Married
Timeline
Senior Manager - BD, Sales and Marketing, Techno Commercial, Operations and Projects
Alivira animal health limited
08.2022 - Current
Manager - Regulatory Affair API
NGL Fine chem Limited
11.2021 - 08.2022
Assistant Manager - Techno commercial API
Alivira Animal Limited
07.2019 - 11.2021
Assistant Manager - Regulatory Affair API
USV Private Limited
07.2018 - 06.2019
Sr. Executive - Regulatory Affairs
Alivira Animal Health Limited
08.2016 - 06.2018
Regulatory Affair Executive
Unique Chemicals (A division of J. B. Chemicals and pharmaceuticals Ltd.)
09.2015 - 07.2016
Quality Assurance Manager and Regulatory Affair Manager
M/s Danashmand Organic Pvt. Ltd.
07.2012 - 03.2015
HOD (Anatomy, Physiology and Pathophysiology Dept)
V.M.H.P. shah College of Pharmacy
06.2009 - 06.2012
Laboratories Griffon Pvt. Ltd. (Franco Indian Pharmaceuticals)
08.2006 - 05.2007
HOD - Anatomy, Physiology and Pathophysiology Dept
V.M.H.P. shah College of Pharmacy
Masters of Pharmacy -
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