NISHA N
Senior Regulatory Affairs
Chennai
Summary
New Zealand, US, with a focus on Submission build and publishing activities. Seeking a Senior Regulatory Affairs position at Navitas Lifesciences, where I bring my regulatory affairs and submission skills to support your mission of providing leading regulatory and compliance services.
Pursuing full-time role that presents professional challenges and leverages interpersonal skills, effective time management, and problem-solving expertise.
Overview
5
5
Languages
17
17
years of professional experience
Work History
Senior Regulatory Affairs
Navitas Lifesciences
Chennai
09.2016 - Current
- Facilitated initial product registration dossier submissions and addressed application queries for Australia and New Zealand. Handled post-approval tasks, including renewals, amendments, and annual reports for multiple products. Delivered comprehensive CMC responses for US market submissions, including CBE-0 and CBE-30. Maintained ongoing general correspondence related to regulatory affairs across ROW countries.
- Proficiency with eCTD and NEES submission processes and publishing.
- Collaborated with international team on contributor handoff timelines.
- Managed submission progress and presented metrics to management.
- Offered mentorship and development for new team members
- Consulted with internal and external clients regarding project progress
- Facilitated punctual submission of all scheduled materials to HA. Examined late submissions and reported findings on trends. Delivered comprehensive metrics report on missed submissions to management.
- Specialized in tools - Pearl, GDMS, Liquent, Insight, Lorenz, validation, Veeva, Rosetta, Phoenix, eCTD, Express, Viewpoint.
- Accelerated dossier preparation timeline by 30% via streamlined methodologies.
- Guided more than 10 new team members, increasing team productivity by 20%
- A top-tier provider of regulatory and compliance support
- Used critical thinking to break down problems, evaluate solutions, and make decisions.
Executive - Regulatory Affairs
The Madras Pharmaceuticals
Chennai
08.2013 - 08.2016
- Coordinated preparation and review of CMC part DS and DP dossiers for CTD & ACTD submissions in all ROW markets and tender preparations.
- Led cross-functional teams to streamline product development processes and enhance operational efficiency.
- Developed strategic partnerships with key stakeholders to drive innovation in pharmaceutical solutions.
- Oversaw compliance initiatives, ensuring adherence to industry regulations and quality standards.
- Addressed queries from country authorities regarding product registrations
- A pharmaceutical company focusing on drug manufacturing and regulatory affairs
Executive - Packing Department
Medopharm Pvt. Ltd
Chennai
01.2010 - 02.2011
- Oversaw packing operations until warehouse stages
- Conducted periodic quality checks for solid dosage form packing
- A pharmaceutical company specializing in medicines and drug formulations
Education
M.Pharmacy - Pharmaceutics
Madurai Medical College
Madurai06-2013
B. Pharmacy - undefined
Madurai Medical College
Madurai06-2009
Skills
* Analytical Skills: Excellent analytical and problem-solving abilities
* Time management
* Teamwork and collaboration
* Attention to detail
* Dependable and responsible
* Active listening
Timeline
Senior Regulatory Affairs
Navitas Lifesciences
09.2016 - Current
Executive - Regulatory Affairs
The Madras Pharmaceuticals
08.2013 - 08.2016
Executive - Packing Department
Medopharm Pvt. Ltd
01.2010 - 02.2011
B. Pharmacy - undefined
Madurai Medical College
M.Pharmacy - Pharmaceutics
Madurai Medical College