Spandana Atluri
Associate Manager
Bangalore
Summary
Spandana is a dynamic professional with rich experience of 11 years in US, EU&ROW Healthcare Industry with 05 years exclusively in Clinical trial experience and 06 years’ experience in Regulatory Affairs Submissions and Project Management. Scheduling transition, and Implementation, Risk Assessment, Reporting & Analytics with Data mapping, Documentation, & Team Management within Pharmaceuticals and Medical Devices.
Overview
12
12
years of professional experience
3
3
Languages
Work History
Associate Manager Submission Specialist
Baxter Innovation Lab
07.2023 - Current
- Initiated process improvements based on thorough analysis of internal operations data resulting in enhanced productivity levels for Veeva implementations.
- Managed cross-functional projects; stakeholder requirements and salesforce based platform improvements ensuring timely completion and alignment with regulatory standards and company objectives on Veeva EDC.
- Led team meetings regularly to discuss progress updates, identify challenges or roadblocks, and provide guidance towards successful project completion.
- Providing demo live and support for stakeholders and colleagues in adopting best Veeva practices in CTMS, RIM and submissions through out product life cycle management.
- Enhanced team productivity by implementing efficient project management strategies.
Research Scientist IV
Aurobindo Pharma Limited
12.2019 - 05.2023
- Acquired cognitive knowledge about the concepts of pharmaceutical management & regulatory guidelines, submission content plans to work close with health authorities (US/EMA/ROW Markets).
- Acquired knowledge in design & evaluation of programmed Multi Particulate Drug Delivery System.
- Actively worked with cross functional teams to implement CAPA.
- Reviewing approvals for label launch for region language specific design, quality and control.
- Supporting post market surveillance for regulated products in India, regulatory liaisoning with authorities and ensure timely initial, renewal and variation approvals; including availability of valid licenses.
- Preparing RA expert response for deficiency letters from various regulatory authorities, preparing QIS, QOS, Annexures, covering letters as per country specific guidelines
Clinical Operations Specialist
Quintiles, TCS and Sipra Labs Limited
02.2014 - 06.2019
- Coached 5 processes to higher level of maturity by improving their process and ensuring they adhered to life cycle development and quality framework in CTMS.
- Removed numerous obstacles and managed risks to enable team efficiency and effectiveness as per eTMF quality principles and facilitation skills.
- Assist with the implementation of corrective actions when appropriate and revise CRF annotations and database data specifications.
- Taking care of access control measures, audit and accountability, Identification and authentication, system and communication protection.
- Interacted with clients to understand business problems and provided end-to-end solutions to address them. Conducted interview with 03 employees in service management team.
- Incident management and service management for RIMS, VEEVA vault software.
- Strong analytical skill with ability to collect, organize and analyze the data using MS Excel. Experience in creating dashboards for performance KPI and pending waivers.
- Worked with guidance on activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
- Training and mentoring provided to the team in timely manner to achieve the goals in a business structured model (e-TMF, CRF, Administrative legal documentation and Protocol review).
- Keenly worked in the start-up process including reviewing protocols, reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings.
Education
PG Diploma - Patents Law
Nalsar University
03.2019
Masters - Pharmaceutical Sciences
Jawaharlal Nehru Technological University
01.2014
Bachelors - Pharmacy
Jawaharlal Nehru Technological University
10.2011
Skills
- EDC, CTMS, RIMS, VEEVA VAULT
- Handling DCGI, CDSCO, FDA,EMA, Emerging Regulatory Bodies
- Regulatory Compliance; 21 CFR Part 11
- Microsoft Office
- Microsoft PowerPoint
- Healthcare Analytics & Reporting
References
Ratin, Sharma, ratin.sharma@tcs.com, +918744025777, Tata Consultancy Services
Interests
Playing Badminton and throwball, Volunteering for NGOs, Aspiring Carnatic Vocalist
Internships
Masters Internship, Indian Institute of Chemical Technology, Hyderabad 2012 — 2013
Courses
- BASE SAS 9.3, Loadstone Learning 2013 — 2014
- Patents Law, Nalsar University 2018 — 2019
- Regulatory Affairs Program on Biologics, Medical Devices & Pharmaceutical Products, Duke University (e-programme) 2023 — 2023
Accomplishments
- Presented ISO 14971: Navigation to risk management for medical devices.
- Variation submission support role in Change Control Management; Veeva vault submissions.
- Baxter Project appreciation award April 2025
- TCS-GSK work excellence award March 2017
- Actively participated in activities across organizations during events.
Software
SAS 93
Veeva RIM
Timeline
Associate Manager Submission Specialist
Baxter Innovation Lab
07.2023 - Current
Research Scientist IV
Aurobindo Pharma Limited
12.2019 - 05.2023
Clinical Operations Specialist
Quintiles, TCS and Sipra Labs Limited
02.2014 - 06.2019
Masters - Pharmaceutical Sciences
Jawaharlal Nehru Technological University
Bachelors - Pharmacy
Jawaharlal Nehru Technological University
PG Diploma - Patents Law
Nalsar University
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