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Biopharmaceutical Product Development

$250/hr Starting at $250

I am an experienced Biopharma program director in business of Biopharmaceutical products. I have grown up the value chain by living through the experience of development of Biologicals. I have lived through the journey of development all the way from bench level researcher in process development leading into guiding a group of cross functional leaders. In this journey, I have gained valuable experience through leading cross functional teams in areas of Research and Development, Operations, Quality, regulatory, Intellectual property, project and program management, Business development and finance. The team developed and managed entire value chain of product development. I managed P&L of the various program related cost and risk management. I have successfully led the teams to approval of products in various emerging markets.  I successfully led team to apply MAA in Japan leading to approval. The team has been awarded several times for the efforts.  In addition I have also learnt the art of product development in various areas of techno-commercial space, program and alliance management. I have had experience with different regulatory agencies like EMA, FDA, PMDA, MHRA, MPA, BfrAM and PMDA in filing, meetings as well as regulatory advice. I have also been instrumental in various due diligence in-licensing and out licensing of products and have successful alliance with partners. I have received several individual and team awards during my career.

On my style of leadership, I have been mapped as gently assertive yet realistic, hardworking yet smart, focused, practical, take people along and collaborative and quick decision maker. I also incorporate various aspects social and emotional intelligence in my professional work.

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$250/hr Ongoing

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I am an experienced Biopharma program director in business of Biopharmaceutical products. I have grown up the value chain by living through the experience of development of Biologicals. I have lived through the journey of development all the way from bench level researcher in process development leading into guiding a group of cross functional leaders. In this journey, I have gained valuable experience through leading cross functional teams in areas of Research and Development, Operations, Quality, regulatory, Intellectual property, project and program management, Business development and finance. The team developed and managed entire value chain of product development. I managed P&L of the various program related cost and risk management. I have successfully led the teams to approval of products in various emerging markets.  I successfully led team to apply MAA in Japan leading to approval. The team has been awarded several times for the efforts.  In addition I have also learnt the art of product development in various areas of techno-commercial space, program and alliance management. I have had experience with different regulatory agencies like EMA, FDA, PMDA, MHRA, MPA, BfrAM and PMDA in filing, meetings as well as regulatory advice. I have also been instrumental in various due diligence in-licensing and out licensing of products and have successful alliance with partners. I have received several individual and team awards during my career.

On my style of leadership, I have been mapped as gently assertive yet realistic, hardworking yet smart, focused, practical, take people along and collaborative and quick decision maker. I also incorporate various aspects social and emotional intelligence in my professional work.

Skills & Expertise

BiopharmaceuticalsConcept DevelopmentLicensing ConsultingProgram ManagementResearch

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