Pallavi Tayade Email & Phone Number | Strategic regulatory affairs professional, thinker with thorough understanding and demonstrated ability in writing and compiling high quality CTD, ACTD dossiers for emerging markets. Achieved several dossier approvals. Working on below profile- • Cross functioning with Stakeholder of different countries throughout the registration & re-registration phase of product to achieve the registration in given timeline. • Responsible for dossier preparation, review, variation & renewals of the product registrations as per the current prescribed guidelines of Africa, Eurasian Economic Union (EAEU), CIS, LATAM and ASEAN markets. • Analyzing new changes in regulatory requirements and discussing same with the management. • Developed excellent relationships with internal functional departments, representative office [Russia] & contract manufacturing sites to achieve timely dossier submission. • Maintaining country wise up-to-date registration status. • Artwork (labeling) development & review for country wise compliance. • Working on multiple projects – MAI claims, BE studies, Brand name registration in India, ISO certification, Pharmacovigilance etc. • Timely responding to queries raised by client and health authorities. • Checking the compliance of quality documents as per current regulatory guidelines • Representing Regulatory perspectives in new product development meetings. • Co-ordinating with business development team to open new markets, planning product wise registration priority to meet commercial revenue targets. • Developing & planning of effective regulatory strategies to meet the business need of organization. • Studying the new markets & discussing the opportunities in same with management Technical Expertise: • Stability Study, Process Validation, Analytical method validation, DMF, PSUR, SPC, PIL, PI, Labeling, Nutraceuticals, CMC • Regulatory guidelines-EU, GMP, ICH, WHO • Dossiers -: CTD & ACTD

Pallavi Tayade

Strategic regulatory affairs professional, thinker with thorough understanding and demonstrated abil...
Mumbai, Maharashtra, India

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Pallavi Tayade’s Email pallavi.tayade@gsk.com

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Pallavi Tayade’s Location Mumbai, Maharashtra, India

Pallavi Tayade’s Current Industry Genpact

Pallavi Tayade’s Prior Industry Edge Pharma | Akriti Pharmaceuticals

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Work Experience

Genpact

Lead Associate

2020-09-01 00:00:00 - Present

Edge Pharma

Regulatory Affairs Sr. Executive

2016-12-01 00:00:00 - 2020-09-01 00:00:00

Akriti Pharmaceuticals

Senior Officer

2016-03-01 00:00:00 - 2016-12-01 00:00:00

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FAQ About Pallavi Tayade

Pallavi Tayade is located at
Mumbai, Maharashtra, India

Pallavi Tayade is a Strategic regulatory affairs professional, thinker with thorough understanding and demonstrated ability in writing and compiling high quality CTD, ACTD dossiers for emerging markets. Achieved several dossier approvals. Working on below profile- • Cross functioning with Stakeholder of different countries throughout the registration & re-registration phase of product to achieve the registration in given timeline. • Responsible for dossier preparation, review, variation & renewals of the product registrations as per the current prescribed guidelines of Africa, Eurasian Economic Union (EAEU), CIS, LATAM and ASEAN markets. • Analyzing new changes in regulatory requirements and discussing same with the management. • Developed excellent relationships with internal functional departments, representative office [Russia] & contract manufacturing sites to achieve timely dossier submission. • Maintaining country wise up-to-date registration status. • Artwork (labeling) development & review for country wise compliance. • Working on multiple projects – MAI claims, BE studies, Brand name registration in India, ISO certification, Pharmacovigilance etc. • Timely responding to queries raised by client and health authorities. • Checking the compliance of quality documents as per current regulatory guidelines • Representing Regulatory perspectives in new product development meetings. • Co-ordinating with business development team to open new markets, planning product wise registration priority to meet commercial revenue targets. • Developing & planning of effective regulatory strategies to meet the business need of organization. • Studying the new markets & discussing the opportunities in same with management Technical Expertise: • Stability Study, Process Validation, Analytical method validation, DMF, PSUR, SPC, PIL, PI, Labeling, Nutraceuticals, CMC • Regulatory guidelines-EU, GMP, ICH, WHO • Dossiers -: CTD & ACTD