Regulatory Affairs Data Management

RAJESWARI BELLAMKONDA

Junior Officer- Regulatory Affairs

Email: *.************@*****.***

Contact: 978-***-****

PROFESSIONAL SUMMARY

• Highly motivated and detail-oriented pharmaceutical sciences professional with over 3 years of combined experience across key domains including Regulatory Affairs, Pharmacovigilance, Clinical Research, and Clinical Data Management.

• Demonstrated expertise in preparing, compiling, and reviewing regulatory documents and dossiers in accordance with global submission standards (e.g., CTD, eCTD).

• Well-versed in international regulatory requirements and guidelines, including ICH, FDA, EMA, ensuring all deliverables meet compliance and quality benchmarks.

• Hands-on experience in pharmacovigilance activities, including Individual Case Safety Reports

(ICSRs), signal detection, Periodic Safety Update Reports (PSURs), and adverse event monitoring in clinical trials.

• Skilled in clinical data management processes, including data collection, validation, and reconciliation using industry-standard tools and systems such as Oracle Clinical and MedDRA.

• Strong understanding of clinical trial operations, including protocol review, ethics submissions, site coordination, and regulatory submissions for investigational products.

• Proven ability to collaborate cross-functionally with clinical teams, regulatory personnel, QA/QC departments, and medical writers to ensure seamless execution of regulatory and clinical projects.

• Competent in using software and databases like RAIS, Argus Safety, CTMS, and CDMS, enhancing efficiency in regulatory tracking and documentation.

• Holds a Master’s degree in Pharmaceutical Sciences from the University of Massachusetts Lowell (2022– 2023), providing advanced knowledge of drug development, regulatory frameworks, and pharmacology.

• Earned a Bachelor of Pharmacy from Acharya Nagarjuna University (2015–2019), forming a solid foundation in pharmaceutical sciences and healthcare regulation. TECHNICAL SKILLS

• Pharmacovigilance Systems & Tools: Argus Safety, ARISg, VigiFlow, MedDRA (Medical Dictionary for Regulatory Activities), WHO-Drug Dictionary

• Clinical Data Management Systems (CDMS): Oracle Clinical, OpenClinica, Medidata Rave, REDCap, Clintrial

• Clinical Trial Management Systems (CTMS): Siebel CTMS, Medidata CTMS, BioClinica CTMS

• Regulatory Submission Tools: eCTD Tools (Lorenz docuBridge, Extedo eCTDmanager), RAIS (Regulatory Affairs Information System), Veeva Vault RIM

• Documentation & Productivity Tools: Microsoft Office Suite (Word, Excel, PowerPoint, Outlook), Adobe Acrobat Pro, SharePoint, TrackWise

• Project & Data Collaboration Tools: MS Teams, Zoom, JIRA, Trello, Smartsheet, Confluence

• Statistical & Analytical Tools (Basic): SAS (basic understanding), SPSS (for research projects), Excel

(PivotTables, Data Validation)

• Regulatory & Quality Guidelines: ICH Guidelines (ICH E6 R2, ICH M4), GCP (Good Clinical Practice), GLP

(Good Laboratory Practice), GVP (Good Pharmacovigilance Practices), FDA, EMA, CDSCO, WHO

• Audit & Compliance Systems: CAPA Management Systems, Document Control Systems, Internal Audit Tools CORE COMPETENCIES

• Preparing and reviewing CTD/eCTD regulatory dossiers

• Submitting regulatory applications to USFDA, EMA, and ROW markets

• Managing ICSR, PSUR, and signal detection in pharmacovigilance

• Handling clinical data using CDM systems and tools

• Drafting medical documents and ensuring labelling compliance

• Coordinating clinical trials and supporting regulatory submissions

• Using RAIS and tracking tools for regulatory project management

• Assisting in audit preparation and inspection readiness

• Managing product lifecycle changes and variation filings

• Collaborating with cross-functional teams to meet project goals CERTIFICATIONS

• Pharmacovigilance

• Clinical Data Management

• Regulatory Affairs

• Clinical Research

EDUCATION

• University of Massachusetts Lowell, USA - Masters in Pharmaceutical Sciences 2022 – 2023

• Acharya Nagarjuna University, India - Bachelor of Pharmacy (B. Pharm) 2015 – 2019 EXPERIENCE

Junior Officer, Hetero Drugs Limited, Hyderabad Jan 2020 – Dec 2022

• Prepared and compiled comprehensive regulatory submissions including Common Technical Documents

(CTD) and electronic CTDs (eCTD) for multiple international markets, specifically USFDA, EMA, and ROW regions.

• Reviewed submission content for accuracy, compliance, and completeness in alignment with global regulatory guidelines (ICH, FDA, EMA), ensuring high-quality documentation.

• Managed post-approval regulatory activities, including variation filings, renewals, labeling updates, and response preparation to regulatory authority queries, contributing to timely market approvals.

• Coordinated with cross-functional departments Formulation Development, Quality Assurance (QA), Quality Control (QC), and Marketing to collect and validate scientific, manufacturing, and administrative data required for submissions.

• Ensured consistency and integrity across all technical documents by performing internal quality control checks before final submission.

• Maintained up-to-date regulatory trackers, submission logs, and status reports to support project planning and documentation traceability.

• Participated in internal audits and facilitated external regulatory inspections, ensuring complete preparedness by aligning documentation and practices with SOPs, GxP, and regulatory standards.

• Collaborated with the regulatory strategy team to interpret updates in global regulations and incorporate changes into submission planning.

• Drafted and reviewed regulatory correspondence, deficiency responses, and supplementary documents to address health authority queries and requests efficiently.

• Utilized Regulatory Affairs Information Systems (RAIS) and document management tools to track submission history, version control, and workflow status.

Regulatory Affairs Intern, Hetero Drugs Limited, Hyderabad Jan 2019 – Dec 2019

• Gained hands-on experience in compiling and organizing regulatory submissions, including preparation of Common Technical Document (CTD) and electronic CTD (eCTD) modules for initial filings and lifecycle management.

• Assisted senior regulatory officers in the updating and maintenance of product dossiers, ensuring accuracy and alignment with evolving regulatory requirements and product lifecycle changes.

• Participated in the review and collation of technical documents, including Module 1 administrative documents and quality-related content in Modules 2 and 3.

• Supported the tracking of regulatory guidelines, circulars, and notices issued by global health authorities (e.g., USFDA, EMA, CDSCO), and contributed to regulatory intelligence databases.

• Maintained accurate documentation logs, submission timelines, and internal version control in compliance with Standard Operating Procedures (SOPs) and Good Documentation Practices (GDP).

• Attended internal meetings with regulatory teams to observe submission planning, risk assessment, and regulatory strategy development.

• Contributed to regulatory audit readiness by organizing document repositories and verifying completeness of supporting information for pre-approval inspections.

• Assisted in preparing regulatory correspondence, including cover letters, summary documents, and requests for information (RFIs) under the supervision of senior team members.

• Developed familiarity with industry terminology, submission structures, and documentation software used in global pharmaceutical regulatory environments.

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