Maithali Deshpande

Regulatory Affairs Executive at Roche Pharmaceuticals

Role: Regulatory Affairs Executive at Roche
Location: Mumbai, IN
LinkedIn followers: 500 followers

Research & DevelopmentView LinkedIn profile

About Maithali Deshpande

I am expert in Provide and implement submission strategies associated with the…

Experience

Regulatory Affairs Executive
Roche
Jul 2008 — Present
Write high-quality CMC and other documents for submission, respecting agreed global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.Prepare and submit different types I and type II variations to the competent authorities (MHRA). To ensure that the SOP’s are followed.To assist in preparation and submission of PSUR‘s. Evaluation of technical documents from research centre and manufacturing locations.Coordinating with the strategic heads for sourcing development, QA, Manufacturing and other teams involved in scheduling and planning.

Contact information

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Current company

Roche

Biotechnology Research · 108K employees · Switzerland 🇨🇭, Switzerland

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI). For more information, please visit https://careers.roche.com Read our community guidelines here: https://www.roche.com/some-guidelines.htm #Roche #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation

roche.com

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