Rachna Dogra
Chandigarh
Summary
Seasoned professional with more than 10 years of experience in various aspects of regulatory affairs. I am seeking a leadership position where I can leverage my experience, knowledge and skills to drive organizational growth and deliver sustainable results.
Overview
11
11
years of professional experience
Work History
Senior Regulatory Affairs Specialist
ICON plc
Bangalore
06.2023 - Current
- Managed day-to-day RIMS activities, including application creation (MAA, BLA, CTA, ELA, NDA), CMC activities, lifecycle management, response to questions, tracking approvals, submissions, registration updates, and documenting post-approval changes in Veeva.
- Managed clinical trial application activities within Veeva, ensuring compliance and timely submissions.
- Facilitated health authority interactions by creating and documenting HAQs in RIMS, responding to queries, and managing regulatory communications.
- Supervising data entry and verification of data in company's RIM system and external agency databases.
- Supervising data remediation and enrichment activities in Veeva vault (RIMS)
- Perform impact assessments for regulatory changes Assess impact of new/updated regulations on existing processes, systems, and data; define implementation roadmap and compliance strategy.
- Coordinated with regulatory leads to ensure timely completion of critical regulatory tasks.
- Collaborates with other submission and management teams to review requests and identify recurring issues, and trends.
- Health assessment for Client’s IDMP data alignment
Senior Drug safety specialist
Parexel International Ltd.
Chandigarh
11.2015 - 06.2023
- Created and amended market authorization applications (MAA) for various procedures in RIMS, regulatory objectives, and registrations in Veeva Vault.
- Performed quality review for MA discontinuation (Withdrawals, Expirations, Transfers), license renewals and labelling changes with 100% accuracy and completeness.
- Performed quality checks of regulatory data entry to ensure high quality in accordance with client SOPs and regulatory requirements.
- Executed data migration from iRiS to SHARE (Liquent Insight), creating applications, registrations, regulatory events, and product detail sets for various medicinal products, devices, cosmetics, and nutraceuticals.
- Performed pre and post approval activities across RIMS for RIM objects, maintaining lifecycle state to meet client needs.
- Delivered regulatory support to clients according to service level agreements.
- Scheduled and facilitated client meetings to address queries and develop strategic plans.
- Consulted with Data Owners, System Owners, ITS, and Data Governance (DG) teams to create new dictionary values and keep them updated and compliant with current guidelines.
- Gained foundational knowledge of IDMP, ISO guidelines, and SPOR standards.
Education
M. Pharmacy -
UIPS, Panjab University
Chandigarh, India08-2015
Skills
- VEEVA vault
- SHARE (Liquent insight)
- Knowledge about Global regulatory authorities
- ICH guidelines
- Data integrity
- Application management
- Regulatory submissions
- Lifecycle management
- Submission tracking
- Effective communication
- Attention to detail
- Global regulatory affairs
- Interpersonal communication skills
- Time management
- Self-directed
- Verbal communication
- Multitasking
Languages
- English
- Hindi
- Punjabi
Personal Information
Date of Birth: 08/11/91
Disclaimer
I hereby declare the information given above is true to the best of my knowledge and belief.
Timeline
Senior Regulatory Affairs Specialist
ICON plc
06.2023 - Current
Senior Drug safety specialist
Parexel International Ltd.
11.2015 - 06.2023
M. Pharmacy -
UIPS, Panjab University