Bharat Kumar Bangarapu

About Bharat Kumar Bangarapu

Currently i am working as Regulatory Project Manager at Freyr Solutions, My core competencies include managing submissions, coordinating cross-functional teams, and ensuring compliance with regulatory requirements and strategies. I independently manage submissions and co-lead working groups for major global markets. I work with functional sub-teams to develop and maintain timelines, schedule and facilitate kick-off meetings, and keep the team on track and accountable. I also have experience in Dossier Preparation and compilation, document review and has further handled positions such as Regulatory Change Manager, Hub Submissions Manager, Single Point of Contact etc for US, CA, EU, and ASEAN markets, where I partnered with product teams and third-party partners to deliver regulatory dossiers. I am motivated by the opportunity to contribute to the development and delivery of innovative and safe products that improve the lives of patients and consumers. I value collaboration, learning, and quality, and I bring diverse perspectives and experiences from my education and work background.

Experience

1. Regulatory Project Manager

   Freyr Solutions

   Sep 2023 — Present · Hyderabad, IN

   Independently manages submissions (and supports internal RPM in managing initial major global filings).• Co-leads SWGs with the designated regulatory lead for non-major global markets MAAs and supplements• Work with functional sub-teams to develop timeline based on data availability and other critical path activities. Identify critical path to submission. Maintain timeline during project lifecycle.• Schedule kick off meeting and create draft agenda with GRL/EMRL or Reg Lead and work with cross-functional team to gather presentations. Provide agenda for kick off prior to meeting.• Facilitate Kick Off. Represent Project Management at Kick Off.• Keep team on track and hold team members accountable to represent function.• Send meeting minutes to team for input and save final minutes to InterACT• Record and track action items. Record decisions made and document in decision log for major decisions.• Create and maintain submission timeline in Project Plan. Confirm RPP is updated as necessary.• Perform scenario planning to identify possible outcomes based on identified risks.• Attend functional sub-team meetings for module 2-5 for tracking of high-level submission timelines, risk identification, and overall alignment.• Create doc plan/content plan in collaboration with functional sub-teams. Confirm adequate time allowed for publishing. Maintain doc plan/content plan to ensure timely hand-off of final documents from functional sub-teams. • Initiate and manage rapid response team for agency questions, including creation of timeline. • Schedule Kick-off and Cross Functional Team Meetings (as necessary) for Meeting Request (MR) & Briefing Book (BB) preparation. Document decisions & action items• Manage authoring, reviewing and approval process for regulatory owned documents as necessary.• Schedule working team meeting, roundtable discussion, meeting preparation & team rehearsal, post-meeting debriefs for HA Meetings

Education

• UC Irvine

  Course Certification, Project Management Specialization

  2024 — 2024

• Osmania University

  Bachelor of Pharmacy - BPharm

  2013 — 2017