
Timeline
Skills
Regulatory affairsPharmaceutical industryGmpEctdValidationFormulationTechnology transferRegulatory submissionsFdaRegulatory requirementsQuality assuranceChange controlOncologyStrategyQuality systemQuality controlGlpManufacturingCmc regulatory affairsElectronic common technical documentAbout me
Experienced professional with a unique combination of technical expertise, managerial experience and business leadership I have worn many hats in my career, having worked in a college, pharmaceutical manufacturing (tablets, capsules, injectables), formulation development, quality control, quality assurance, and currently heading the Regulatory Affairs function, responsible for global submissions. As a result of my varied experience, I am able to understand the challenges with respect to each aspect of a regulatory dossier. I have the ability to respond to challenges with confidence, determination, and clear focus on business initiatives. Specialties: Regulatory Strategy, Regulatory submissions, Post-approval activities, Compliance and Training
Education

Birla institute of technology
1990 - 1992Masters in pharmacy
Birla institute of technology
1986 - 1990Pharmacy
D b m s english school
1970 - 1985School graduation
Indian school of business
2011 -Stepping into leadership
Insead
2014 -High impact leadership program
Indian institute of management, indore
2017 - 2017Management development programme
Experience

Sanofi-aventis
Jan 1997 - Jan 2002Assistant manager
Dabur pharma limited
May 2003 - Dec 2008Manager, global regulatory affairs
Fresenius kabi oncology limited
Jan 2009 - Dec 2011Assistant director, global regulatory affairs
Fresenius kabi oncology limited. - india
Oct 2011 - Jun 2023Senior Director, Regulatory Affairs
Aug 2008 - Jun 2023Joint Director, Regulatory Affairs
Jan 2014 - Dec 2015Associate Director, Regulatory Affairs
Oct 2011 - Dec 2013

Fresenius kabi oncology limited
Jan 2023 - nowVice president regulatory affairs
Licenses & Certifications
- View certificate

Raps member
Regulatory affairs certification programFeb 2010 - View certificate
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Raps member
Regulatory affairs professionals society (raps)Feb 2010 - View certificate

Raps member
Regulatory affairs certification programFeb 2010 - View certificate

Raps member
Regulatory affairs certification programFeb 2010
Languages
- enEnglish
- hiHindi
- puPunjabi
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