Yogesh Sharma

Senior Consultant (Senior Manager Freyrsolutions Consulting) for Takeda @Takeda

IN

Collaborates to define, develop and lead Marketed Products strategies.• Manages, plans and executes all aspects for the successful preparation, submission and timely approval of investigational applications, market applications, variations, post-approval reporting obligations and general product life cycle management of the assigned program.• Effectively communicates the regulatory strategies, submission plans and timelines; and impact assessments of trends, regulations and changes related to assigned programs.• Provides regulatory expertise on Marketed Products for multiple projects including registration and / or post-marketing compliance and life cycle management.• Develops effective working relationships with Local Regulatory Lead, Regional and Global Regulatory Team, Cross-functional teams, company’s consultants and Business Partners• Evaluates new business development opportunities for Growth and Emerging Markets and/or participates on due diligence teams.• In coordination with local regulatory lead provides strategic guidance/advice on emerging trends, regulations and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs.• Leads or supports preparation activities for meetings with Health Authorities for the assigned program, as required. Interacts directly with HA, as required. Represents Takeda Marketed Products in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps, as required.• Manages, trains, and provides direction, strategic guidance, and solutions to projects, mentors team members, if required, to support the scope of project work• Partner with the regional/LOC market access and LOC RA colleagues to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into regional product development plans.

Dr. APJ Abdul Kalam Technical University, Lucknow, India

M. Pharm, Pharmaceutics

Rajiv Gandhi University of Health Sciences

B.Pharm, Pharmacy