AKHILA KUMMARI
Hyderabad,Telangana
Summary
Multifaceted, efficient, and reliable professional with nearly 10 years of cross-functional experience in the Biopharmaceutical industry, primarily in Biosimilars being developed for the global market.
Overview
10
10
years of professional experience
Work History
Sr. Manager - Project Mgmt. & Regulatory Affairs
GeneSys Biologics Private Limited
12.2022 - Current
- Develop detailed project plans with timelines, milestones, deliverables, and resource allocation for global regulatory submissions for Biosimilars (e.g. US, Rest of the World) at all stages of development i.e. Phase 1 through approval
- Responsible for fostering and maintaining robust relationships with both internal and external partners to ensure project alignment with respect to execution and focusing on deliverables
- Facilitating cross-functional team workshops, shared collaboration and communication across different departments (Bioprocess and Analytical, Quality, MSAT, Manufacturing, Multisite etc.)
- Monitoring the project progress, identifying potential risks, and implementing mitigation strategies
- Responsible for identifying and addressing potential bottlenecks like resource gaps
- Regulatory Submissions - Planning and execution of regulatory submissions including the compilation and review of CMC, non-clinical data, clinical data
- Taking lead on the scientific advisory meeting packages for health authority meetings - US FDA, EMA, India, SFDA
- Building the BLA - Collaborating with cross-functional teams to develop and implement regulatory strategies for product submission across the globe and ensuring that the regulatory framework and content is driven by science and data
- Reviewing the technical reports pertaining to DS, DP, and associated QMS aspects during early and late-stage development
- Planning and handling due diligence, customer and regulatory audits
Assistant Manager - Project Mgmt. & RA
GeneSys Biologics Private Limited
07.2022 - 12.2022
- Authored scientific advisory meeting package for health authority meetings, IND & IMPD modules
- Performed gap analysis on draft submission package to ensure the adequacy for submissions - CTA, IND, Dossiers etc
- Co-authored the application to the Technology Development Board in collaboration with the finance team for commercial facility
- Assisted the management in designing the regulatory strategies
- Assisted in developing clinical program for 3 biosimilars - reviewing the protocols & reports
- Responsible for keeping the Organization informed with all the relevant regulatory updates
- Been the knowledge source for any regulatory advice
Senior Executive - Project Management & Regulatory Affairs
GeneSys Biologics Private Limited
12.2019 - 07.2022
- Authored and filed applications for licenses/ approvals
- 3 Clinical Trial Applications for 2 biosimilars - phase 1 & phase 3
- 4 Pre-clinical Application f - Form C3 & Form C5
- Manufacturing License - Form 28D
- Test License (Form 29) & Import Licenses (Form 11/ CT-17 etc.,)
- GEAC Environmental Approval for Clinical Trials (Form IIA)
- IBSC Registration, Minutes & Annual Compliance Reports
- Renewal of DSIR Registration BIRAC Applications for BIPP support
- Responsible for review of technical reports ‑ stability, analytical reports, specifications etc.,
- Continued performing Regulatory Intelligence activities like collating, analyzing, reporting and communicating all the relevant regulatory information and assisting the management
- Shared the feedback with MHRA on the guideline for licensing of biosimilar products
Research Associate - Regulatory Intelligence
GeneSys Biologics Private Limited
11.2017 - 12.2019
- Assisted Management in developing regional & global regulatory strategies
- Drafted regulatory intelligence analysis report on insulin analogs & biosimilars on basis of precedence and regulatory guidelines
- Been the Knowledge source for any regulatory advice through ad hoc requests
- Accountable for communicating updates on advancements in biosimilars
- Performed regulatory research to support the regulatory strategies
Research Assistant - Research & Development
GeneSys Biologics Private Limited
11.2015 - 11.2017
- Responsible for the execution of purification of Inclusion bodies
- Evaluated the suitability of micro-filtration unit operation using different sources
- Responsible for material management of R&D
- Drafted standard operations procedures, instruction records for process
- Responsible for documentation maintenance - instrument installation, service reports
- Compilation and maintenance of MSDS of raw materials
- Assisted the team in performing purification unit operation and data review
Research Trainee - Analytical Development
GeneSys Biologics Private Limited
05.2015 - 10.2015
- Assisted in performing HPLC, SDS-PAGE, Western Blotting
- Prepared buffers for analysis
- Drafted standard operating & testing procedures
- Assisted material management for Analytical lab - sourcing, ordering & receipt
Education
Certification - Project Management Professional
Simplilearn
An Authorized Training Partner Of PMI01-2023
Post Graduation Diploma - Regulatory Affairs
Institute of Good Manufacturing Practices
India09-2018
Master of Technology - Biotechnology
Jawaharlal Nehru Technological University
Kakinada, Andhra Pradesh04-2014
Bachelor of Technology - Biotechnology
R.V.R&J.C College of Engineering
Guntur, Andhra Pradesh04-2012
Skills
- Comprehensive Project Management
- Skilled in Microsoft Office Applications - Project, Presentation, etc,
- Meticulous Attention to Detail
- Multitasking
- Adaptive Learning Ability
- Effective Communication
- Team work & collaboration
- Enthusiastic Reader
Accomplishments
- Critical member of project management and regulatory team right from candidate identification, CMC development, preclinical, clinical phase (phase 1 and 3), preparation of marketing submission
- Achieved timely grant of BIRAC support under BIPP scheme
- Mentored freshers in their professional development by offering guidance & support in their assigned roles
- Team player in successful due diligence & audits
Timeline
Sr. Manager - Project Mgmt. & Regulatory Affairs
GeneSys Biologics Private Limited
12.2022 - Current
Assistant Manager - Project Mgmt. & RA
GeneSys Biologics Private Limited
07.2022 - 12.2022
Senior Executive - Project Management & Regulatory Affairs
GeneSys Biologics Private Limited
12.2019 - 07.2022
Research Associate - Regulatory Intelligence
GeneSys Biologics Private Limited
11.2017 - 12.2019
Research Assistant - Research & Development
GeneSys Biologics Private Limited
11.2015 - 11.2017
Research Trainee - Analytical Development
GeneSys Biologics Private Limited
05.2015 - 10.2015
Certification - Project Management Professional
Simplilearn
Post Graduation Diploma - Regulatory Affairs
Institute of Good Manufacturing Practices
Master of Technology - Biotechnology
Jawaharlal Nehru Technological University
Bachelor of Technology - Biotechnology
R.V.R&J.C College of Engineering
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