Regional Sales Director@ AbbVie
Pine Brook, New Jersey, United States
Ajit Katdare
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Bombay College Of Pharmacy
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FlashIntel GPTAjit Katdare is a highly skilled Regulatory Affairs professional with over seven years of experience in Regulatory Affairs and Compliance. He has expertise in Abbreviated New Drug Application submissions for solid orals and parenteral dosage forms. Ajit is known for his ability to lead regulatory submissions and is an effective independent worker and coordinator. He is RAC (US) certified and has worked at Alvogen in the United States as a Manager, Regulatory Affairs, Senior Associate, and Regulatory Affairs Associate. Ajit has also worked at Metina PharmConsulting Pvt. Ltd. in India as a Regulatory Affairs Consultant.
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About
A qualified and strongly reliable Regulatory Affairs professional with over seven years of experience in Regulatory Affairs and Compliance. Significant experience in Abbreviated New Drug Application (ANDA) submissions for solid orals and parenteral dosage forms. Proven ability to lead regulatory submissions with planning, preparing and submitting applications to meet FDA requirements. Effective independent worker as well as coordinator with other members of the quality team. RAC (US) certified.
Work Experience
Regional Sales Director
Pharmaceutical Manufacturing
Ajit Katdare's Professional Milestones
- Manager | Regulatory Affairs (2018-11-01~): Negotiated and implemented regulatory compliance, ensuring the safety and satisfaction of all stakeholders.
- Trainee In Regulatory Affairs (2008-04-01~2008-07-01): Successfully led complex regulatory examinations, gaining hands-on experience in the field and implementing legal strategies.
Education
Bachelors,
Bachelor Of Pharmacy
2003-2007Skill
Regulatory Affairs
Regulatory Submissions
Anda
Gmp
Generic Programming
Pharmaceutical Industry
Regulatory Documentation
Quality Assurance
Pharmaceutics
Formulation
Ectd
Glp
Ind
Biotechnology
Analytical Chemistry
Quality By Design
Electronic Common Technical Document
U.s. Food And Drug Administration
Abbreviated New Drug Application
Good Laboratory Practice
Validation
Certification
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Ajit Katdare works for AbbVie
Ajit Katdare's role in AbbVie is Regional Sales Director
Ajit Katdare works in the industry of Pharmaceutical Manufacturing
Ajit Katdare's colleagues are Harinath Tiwari,Umer Ch,alok bhadoriya
Ajit Katdare's latest job experience is Regional Sales Director at AbbVie
Ajit Katdare's latest education in Bombay College Of Pharmacy
