Open to opportunities

Anupama Nagaraja

@anupamanagaraja

Message

Accomplished leader in regulatory compliance and quality assurance.

United States

Message

What I'm looking for

I seek a role that fosters innovation and collaboration, with opportunities for professional growth and community impact.

I am an accomplished and results-oriented leader with over 17 years of impactful experience in regulatory compliance, CMC, quality, and drug research and development. My career has been marked by a proven track record of leading global teams and managing complex projects, ensuring adherence to the highest regulatory standards. I have successfully driven cross-functional collaboration across global teams, enhancing operational excellence and fostering innovation in the pharmaceutical and biotech sectors.

Throughout my career, I have been recognized for my strategic leadership and ability to implement corrective and preventive actions that significantly improve compliance and operational efficiency. My expertise spans regulatory strategy, quality management systems, and analytical methods development, enabling me to contribute effectively to market expansions and regulatory submissions. I am dedicated to advancing pharmaceutical innovation while maintaining a strong commitment to community advocacy and volunteerism.

Experience

Work history, roles, and key accomplishments

Current

Consultant

Current

Self Employed

Sep 2023 - Present (1 year 9 months)

Providing consulting services, webinars, and training in regulatory compliance and quality assurance within the pharmaceutical and biotech sectors.

Consulting Regulatory Compliance Training Quality Assurance Webinars Project Management Stakeholder Engagement

Senior Manager Global Vaccines Regulatory Affairs

Takeda

Mar 2023 - Sep 2023 (6 months)

Managed complex relationships and regulatory compliance for vaccine operations, aligning SOPs and improving compliance by 30%. Led cross-functional teams to support market expansions and implemented regulatory notification templates across regions.

Regulatory Compliance Risk Assessment Stakeholder Engagement

Global Biologics Product Science Lead

Takeda

Oct 2021 - Mar 2023 (1 year 5 months)

Led strategic management of commercial and clinical products, driving global market expansion and regulatory submissions. Authored CMC submissions and managed complex regulatory timelines, ensuring compliance with ICH, FDA, and EMA guidelines.

Regulatory Submissions Project Management Cross Functional Collaboration Risk Assessment Stakeholder Management Budget Management Compliance

QC Scientist

Takeda

Jul 2017 - Oct 2021 (4 years 3 months)

Managed regulatory CMC submissions for biologic products, established specifications, and implemented risk mitigation strategies. Led project management for method validations and coordinated testing for compliance.

Quality Control Risk Mitigation Project Management Compliance

Global QC Scientist

Shire

Jun 2016 - May 2017 (11 months)

Oversaw manufacturing operations for biologic products, managed quality assessments, and collaborated with cross-functional teams to ensure timely delivery of high-quality products.

Quality Assurance Regulatory Compliance Cross Functional Collaboration Quality Target Assessments Project Management

Scientist (Analytical)

Biogen Idec

Jan 2015 - Jan 2016 (1 year)

Managed Phase-3 small molecule projects, coordinated cross-functional teams, and supported IND submissions. Led method development and validation for analytical processes.

Project Coordination IND Submission Cross Functional Team Management

Senior Scientist

Novartis Institutes

Feb 2014 - Jan 2015 (11 months)

Facilitated bioanalytical support for small molecule drug development projects, ensuring compliance with regulatory standards and performing method development and validation.

Bioanalytical Support Regulatory Compliance Data Analysis Project Management Documentation

Education

Degrees, certifications, and relevant coursework

Banaras Hindu University

Doctor of Philosophy, Chemistry

2002 - 2006

Achieved a Doctor of Philosophy (Ph.D.) in Chemistry with a specialization in Analytical Chemistry, contributing to significant research in the field.