RAKSHITHA KS
Regulatory Affairs Associate
Salem,TN
Summary
A proactive and detail-oriented Regulatory Affairs professional with 1.5 years of experience in managing regulatory submissions, ensuring compliance with local and international regulations, and supporting the approval process for pharmaceutical and healthcare products. Skilled in preparing and reviewing regulatory documents, addressing health authority queries, and conducting thorough assessments of product dossiers. Well-versed in ICH guidelines, CTD formats, and regulatory requirements across various markets, including the EU, ROW, and ASEAN regions. Demonstrates a strong ability to collaborate with cross-functional teams, interpret complex regulations, and maintain up-to-date knowledge of industry standards. Dedicated to contributing to the timely and successful approval of products while ensuring adherence to regulatory guidelines.
Overview
3
3
years of professional experience
Work History
Regulatory Affairs Associate
Pfizer Healthcare India Pvt Ltd
09.2023 - Current
- Roles & Responsibilities
- Increased compliance rate by analyzing tender documents and addressing regulatory queries across regions.
- Aligned regulatory submissions with ICH guidelines by preparing Module 3 CTD sections and Quality Overviews (QOS).
- Managed variations and submissions by understanding EU, APAC, US and ASEAN market regulations.
- Enhanced submission accuracy by leveraging analytical skills and stakeholder communication.
- Expedited regulatory approval by adapting strategies for complex regulatory processes.
- Evaluated regulatory submissions to ensure compliance with local and international healthcare standards, enhancing approval timelines.
- Coordinated cross-functional teams to address regulatory inquiries, facilitating timely responses and maintaining project momentum.
- Developed and maintained regulatory documentation, ensuring accuracy and adherence to compliance requirements throughout project lifecycles.
- Assisted in the preparation of regulatory filings, contributing to successful product launches and maintaining market access.
- Collaborated with quality assurance teams to align product standards with regulatory requirements, improving overall product quality.
- Monitored regulatory changes and communicated updates to relevant stakeholders, ensuring awareness and adherence to new guidelines.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Managed post-approval changes, ensuring all necessary documentation was submitted accurately and on time.
Intern
GlaxoSmithKline Global Capability Centre
08.2022 - 08.2023
- Roles & Responsibilities
- Prepping Module 1 Documents for variation Filling across Global markets including EU, NZ, AU, ASEAN, ROW, Latin America for both pharmaceutical and vaccine products.
- Worked with cross functional teams and local Operating Teams (LOC) to secure marketing Authorization Approvals, Renewal of Licenses and manage product life cycles.
- Managing Quality, Accuracy & Compliance with internal corporate and Regulatory standards of Documents.
- Conducted comprehensive market research and analysis, contributing to strategic decision-making and improved operational efficiency.
- Collaborated with cross-functional teams to develop and implement process improvements, enhancing team productivity and project outcomes.
- Assisted in the development of training materials and programs, facilitating onboarding and skill enhancement for new team members.
- Streamlined data management processes by implementing a new tracking system, resulting in improved accuracy and accessibility of information.
Education
Master of Pharmacy - Pharmaceutics
JSS College of Pharmacy
Ooty05.2023
PG Diploma - Regulatory Affairs
JSS Academy of Higher Education & Research
Mysuru05.2023
Skills
Veeva vault
Interests
AI tools, Travel
Accomplishments
- Improved compliance rate
- Increased Compliance rates by implementing new ideas within the team.
- Process Optimization
- Streamlined the regulatory Submission process.
- Appreciation from global collegues
- Received bravo awards from Australian tender team lead for actively involving in the tender and supported in a very short timeliness.
COURSES
Undergoing Data Analytic course.
Timeline
Regulatory Affairs Associate
Pfizer Healthcare India Pvt Ltd
09.2023 - Current
Intern
GlaxoSmithKline Global Capability Centre
08.2022 - 08.2023
PG Diploma - Regulatory Affairs
JSS Academy of Higher Education & Research
Master of Pharmacy - Pharmaceutics
JSS College of Pharmacy