Dr. Elisha R Repalle Ph.D

Project Manager

Bengaluru, Karnataka, India21 yrs experience
Most Likely To SwitchHighly Stable

Key Highlights

  • Led compliance initiatives for over 30 IVD devices.
  • Founded and launched a molecular diagnostics startup.
  • Reduced regulatory documentation rework rates by 50%.
Stackforce AI infers this person is a Regulatory Affairs Specialist in the Healthcare and Biotechnology sectors.

Contact

Skills

Core Skills

Regulatory AffairsProject ManagementTeam LeadershipProduct DevelopmentResearch And Development (r&d)

Other Skills

Interpersonal SkillsProblem SolvingData AnalysisTrainingRegulatory RequirementsProduct RequirementsInterpersonal RelationshipsCommunicationHealthcare IndustrySOPProtein PurificationBiochemistryMolecular BiologyPurificationPCR

About

An experienced IVDR professional

Experience

21 yrs
Total Experience
3 yrs
Average Tenure
6 yrs 11 mos
Current Experience

Hcltech

3 roles

Senior Project Manager

Feb 2026Present · 2 mos · India

Project Manager

Apr 2022Feb 2026 · 3 yrs 10 mos · India

  • Supervised the submission of regulatory documents and maintained audit readiness for the entire portfolio of over 30 IVD devices while managing IVDR compliance initiatives.
  • Managed a multidisciplinary marketing team of over 70 people across multiple projects, overseeing resource allocation, KPI measurement, and regulatory milestones.
  • Created and enforced workflows that achieved a 25% reduction in the submission deadlines for the technical documents as a part of the streamlining exercises done by the organization.
  • Served as the primary escalation point for international clients, managing highly complex regulatory issue resolution within contracted timelines.
  • Developed and presented tailored training sessions focused on enhancing onboarding processes that resulted in improved accuracy of documents prepared by the regulatory affairs team.
Regulatory AffairsProject ManagementTeam LeadershipInterpersonal SkillsProblem SolvingData Analysis+1

Senior Lead : Medical Writing

May 2019Jun 2022 · 3 yrs 1 mo · India

  • Senior Lead – Clinical and Scientific Writing
  • HCL Technologies, Bangalore | May 2019 – Jun 2022
  • Managed end-to-end preparation and peer review of Clinical Evaluation Reports (CERs), State of the Art (SOTA) documents, and PMS/PMCF plans under IVDR.
  • Led quality improvement initiatives that reduced rework rates in regulatory documentation by 50% through systematic content standardization and review frameworks.
  • Advised cross-functional regulatory and clinical teams on EU MDR/IVDR requirements to ensure alignment of submission content with applicable regulations.
  • Provided mentorship and regulatory training to junior writers, improving team-wide compliance with internal quality standards and external reviewer expectations.
Team LeadershipInterpersonal SkillsRegulatory RequirementsRegulatory AffairsTrainingData Analysis+1

Major science instruments private limited

Business Development Manager

Jun 2018Feb 2019 · 8 mos

  • Spearheaded market development initiatives for molecular diagnostics products across new regions, increasing product visibility and adoption in academic and research institutions.
  • Established and managed a distributor network in key international markets, providing ongoing technical support and promotional strategies to drive sales growth.
  • Organized and conducted workshops, roadshows, and technical seminars to educate researchers and lab professionals on product applications and benefits.
  • Led cross-functional teams, coordinating efforts between sales, technical, and regulatory teams to ensure successful project execution and client satisfaction.
  • Developed and executed strategic business plans that contributed to increased market share and profitability within target regions.
  • Expanded the client base by identifying high-potential business opportunities and building strong relationships with key stakeholders and decision-makers.

Sun biologicals

Director of Research and Development

Nov 2017May 2018 · 6 mos · Bengaluru Area, India

  • Founded and led a molecular diagnostics startup from concept to operational launch, including market research, business planning, and regulatory engagement.
  • Liaised with regulatory authorities to obtain necessary approvals for company registration and product compliance in alignment with national health regulations.
  • Sourced products through OEM partnerships, negotiating with manufacturers to ensure cost-effective and quality supply for diagnostics and research markets.
  • Developed and implemented SOPs for research operations in molecular biology and proteomics, ensuring consistency, safety, and documentation readiness.
  • Promoted in-house assay kits and molecular products by leading client engagements and technical presentations across academic and clinical institutions.
  • Managed end-to-end project delivery, improving customer satisfaction through on-time fulfillment and responsive technical support.
Team LeadershipProduct RequirementsRegulatory RequirementsResearch and Development (R&D)Product DevelopmentRegulatory Affairs

Dr biosciences llp

Founding Director, DR Biosciences

Jan 2015Nov 2017 · 2 yrs 10 mos · Bengaluru Area, India

  • Directed day-to-day research operations in molecular biology and proteomics, ensuring alignment with scientific and commercial objectives.
  • Led the design and execution of new product development projects, from concept through validation, targeting diagnostics and life science markets.
  • Established strategic partnerships with Indian and international firms for OEM sourcing, technology transfer, and joint development initiatives.
  • Oversaw the preparation of regulatory, technical, and quality documentation to support product readiness and market entry.
  • Coordinated closely with co-directors across R&D, finance, and commercial functions to align company strategy and drive business goals.
  • Played a key role in regulatory liaison and business setup, contributing to the successful establishment and early growth of the organization.
Team LeadershipProduct RequirementsResearch and Development (R&D)Product Development

Biogenex

Research Scientist

May 2013Oct 2014 · 1 yr 5 mos · Hyderabad Area, India

  • Prepared product catalogs for the U.S. and international markets, incorporating technical specifications and compliance considerations.
  • Oversaw the development and release of FISH probes, special stains, and antibody panels, including preparation of supporting documentation and labeling materials.
  • Created technical brochures, product manuals, safety data sheets (SDS), and presentations in alignment with global regulatory and marketing standards.
  • Provided hands-on training to lab personnel on IHC, ISH, and FISH protocols using automated XMatrx systems, ensuring consistency in assay performance.
  • Improved research quality by optimizing experimental designs and introducing enhanced data analysis methodologies.
  • Fostered interdisciplinary research collaborations, resulting in more robust experimental outcomes and increased project scope.
  • Streamlined laboratory workflows to reduce operational costs and enhance productivity across pathology assay projects.
Team LeadershipResearch and Development (R&D)

Life technologies

Technical Application Scientist

Nov 2010Dec 2012 · 2 yrs 1 mo

Team LeadershipResearch and Development (R&D)

Sri krishnadevaraya university

Junior Research Fellow

Mar 2003Oct 2009 · 6 yrs 7 mos

  • Training new PhD students and other Project students in the lab, Designing projects for their thesis work, etc,
  • EDUCATIONAL PROFILE; Training new M.Sc students and other Project students in the lab, Designing projects for their thesis work, etc, The title of my thesis is, ““Heterologous expression and large scale purification of recombinant organophosphate hydrolase (OPH) from E. coli and its use in decontamination of organophosphates and nerve gas agents”
Team Leadership

Education

S.K. University

Doctor of Philosophy (Ph.D.) — Biochemistry

Jan 2003Jan 2009

Srikrishnadevaraya University

Master’s Degree — Biochemistry

Jan 1998Jan 2000

Osmania Degree College for Men

Bachelor’s Degree — Chemistry; Biochemistry & Zoology

Jan 1995Jan 1998

Board of Intermediate Education

Board of Intermediate Education — Zoology; Physics; Chemistry

Jan 1991Jan 1993

Montessori English Medium School

High School

Jan 1991Present

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