Aishwarya Roy
Bangalore
Summary
Highly motivated and results-oriented Regulatory Affairs Specialist with 10.9 years of experience in ensuring timely and compliant submissions for medical devices and drugs. Proven ability to manage projects effectively, lead teams, and exceed expectations. Deep understanding of global regulatory requirements, electronic submission tools (Veeva Vault, eCTD Express), and quality control procedures. Specialized Intelligence Analyst skilled in data gathering and assessment. Application of advanced analytical skills to detect potential threats.
Overview
11
11
years of professional experience
1
1
Certification
Work History
QARA - Intelligence Specialist
Teleflex
Bangalore
02.2025 - Current
- Processed standards and regulatory updates, extracted Gap impact assessment numbers via Agile and routed notifications to Stakeholders and regional teams within 5 business days.
- Coordinated with subject matter experts (SMEs) to complete Gap and Impact Assessments within 120 days of notification; proactively mitigate risks of delays.
- Maintained accurate and up-to-date data in Smartsheet; monitor metrics periodically to identify and address risks or areas of concern.
- Developed and distributed monthly regulatory update emails summarizing changes in standards and regulations.
- Prepared quarterly management review presentations and contributed to regulatory intelligence content for the QARA newsletter.
- Driven continuous improvement initiatives by identifying process enhancement opportunities and managing implementation.
- Ensured effective communication and collaboration across cross-functional teams to support compliance and timely execution of regulatory activities.
Regulatory Affairs Specialist
Baxter Innovations and Business solutions Pvt. Ltd
Bangalore
07.2021 - Current
- Team Management: Led a team of 7-8 regulatory specialists, providing guidance, mentorship, and training to ensure optimal performance and team cohesion.
- Project Management: Successfully managing multiple regulatory projects, ensuring timely delivery and adherence to quality standards.
- Recruitment and Onboarding: Played a key role in recruiting and onboarding new team members, ensuring a smooth transition and effective integration into the team.
- Performance Management: Conducted regular performance reviews, provided feedback, and implemented development plans to enhance team performance and individual growth.
- Regulatory Submissions: Led the successful preparation and submission of e-CTD packages for US, EU, Canada, and ROW markets. Ensured compliance with regulatory requirements while achieving a high success rate. Collaborated with non-regulatory support groups for necessary documentation.
- Managed submissions through Veeva -Vault (RIM). Used electronic document management systems (RIMS, BAXEDGE) to support product renewals.
- Regulatory Strategy: Developed and implemented regulatory strategies to support product development and lifecycle management. Managed and tracked regulatory documentation progress for product renewals, ensuring timely reviews and compliance. Coordinated responses to regulatory authorities and addressed MOH queries for assigned products.
- Stakeholder Management: Effectively communicating with internal and external stakeholders, building strong relationships and ensuring alignment of regulatory goals.
Submission Delivery Specialist (GRPD)
Glaxo Smith Kline
Bangalore
03.2019 - 06.2021
- Submission publishing for US/EU/GCC/ROW markets.
- Publishing Packages using ECTD Express, CSC Publisher in eCTD, NeeS and paper/pdf format.
- Compilation of dossier as per submission planner, naming, generating TOC, publishing and validating the package.
- Pre-publishing and Post-publishing activities such as merging of documents, External Linking, Magnification, Bookmark fixation, QC and optimization using CSC toolbox.
- Reviewing documents as per the submission planner before processing, complying with the documents as per ICH guidelines for various countries.
- Veeva to archive the submission packages. Veeva was also used as source document repository.
Associate, Regulatory Operations (PROS)
PAREXEL International
03.2015 - 03.2019
- Life Cycle Management (e-CTD submissions for US, CA, EU, ROW), using Insight publisher and ECTD Express.
- Expertise in various tools like Mikado (RIMS) wherein clinical study reports are archived and given reference links to track those documents.
- Authoring documents such as cover letters and application forms, batch processing the documents (example CRF) and e-signature.
- Dispatching documents via ESG gateway, EMA gateway and downloading the receipts and acknowledgments.
- Compiled dossiers using the documents provided by the client for various EU countries, US, and ROW.
- Performing all types of Submission and publishing activities using Veeva Vault, e-CTD submissions for US, EU, Swiss, Canada, GCC and Australia using Liquent Insight Publisher.
- Experience of validating the published outputs with various tools (e-CTD reviewer, Insight validator, EURS validator and Lorenz eV) according to the current regulatory guidelines and fixing the errors.
- Perform quality assurance of published output regarding formatting and navigation. Perform quality control of published output for completeness and correctness.
- Answer internal queries for assigned products.
Project Intern
Norwich clinical services
Bangalore
07.2014 - 02.2015
- Observed the role of QA unit in the clinical study.
- Monitored the process of clinical study, went through various regulatory requirements for bioequivalence study such as FDA, EMA and ANVISA.
- Various checklists and documents associated with the clinical study were marked and reviewed.
- Performed precision accuracy batch analysis of the allotted drug.
Education
M.PHARM -
BIRLA INSTITUTE OF TECHNOLOGY AND SCIENCES
05.2015
B.PHARM -
MANIPAL UNIVERSITY
03.2012
XII -
CBSE
03.2008
X -
I.C.S.E
03.2006
Skills
- Regulatory Compliance
- People Management
- Project Management
- VEEVA Vault/RIM
- Regulatory Submissions
- E-CTD
- Quality Assurance
- Data Analyst
- Presentation
- Gap assessment
- Intelligence analysis
- Risk mitigation
Certification
- ISO 13485:2016 Internal Audit training, 05/01/23
- Completed Medical devices awareness trainings on ISO13485:2016, ISO-14971:2019, EU-MDR 2017/745 and IEC 62304, 05/01/23
- Qualified Graduate Pharmacy Aptitude Test (GPAT), 05/01/14
Accomplishments
- Successfully led a team of 7-8 regulatory specialists in preparing and submitting e-CTD packages for US, EU, Canada, and ROW markets, achieving a 98% on-time submission rate.
- Managed project timelines, budgets, and resources to ensure efficient completion of regulatory submissions.
- Mentored junior team members, providing guidance and training on regulatory processes and tools.
- Collaborated with cross-functional teams (manufacturing, quality, clinical) to gather and review documentation for regulatory submissions.
- Developed and maintained strong relationships with regulatory agencies to ensure smooth communication and timely approvals.
- Demonstrated strong presentation skills by preparing and delivering quarterly metrics presentations to leadership, effectively communicating key performance indicators and driving data-driven decision-making.
- Won 1st prize in Antakshari, conducted by the college editorial board.
- Won 3rd prize in the cultural fest named Sanskriti and received a certificate of merit.
Publications
- Impact on clinical trial studies due to regulatory amendments in India, Thakur A, Roy A, Mullapudi S, Pharmacophore- An International Research Journal, 5, 6, 03/01/14
- Recent Trends in Targeted Drug Delivery, Abhimanyu Thakur, Aishwarya Roy, Srijani Chatterjee, Prosenjit Chakraborty, Kamalika Bhattacharya, Partha Pratim Mahata, SM Group (USA), 978-0-9962745-5-5, Dr. Sagar Naskar
Activities
- Volunteer for the 62nd Indian Pharmaceutical Congress, 03/01/10, Participated as a volunteer for the 62nd Indian pharmaceutical congress 2010 and received a certificate of appreciation.
- Member of IPA
Timeline
QARA - Intelligence Specialist
Teleflex
02.2025 - Current
Regulatory Affairs Specialist
Baxter Innovations and Business solutions Pvt. Ltd
07.2021 - Current
Submission Delivery Specialist (GRPD)
Glaxo Smith Kline
03.2019 - 06.2021
Associate, Regulatory Operations (PROS)
PAREXEL International
03.2015 - 03.2019
Project Intern
Norwich clinical services
07.2014 - 02.2015
M.PHARM -
BIRLA INSTITUTE OF TECHNOLOGY AND SCIENCES
B.PHARM -
MANIPAL UNIVERSITY
XII -
CBSE
X -
I.C.S.E