Aparna W

Highly analytical and collaborative Regulatory Affairs with over 4+ years and Quality Control Specialist with over 5 years of progressive experience within sterile API and formulation (OSD & Injectable) manufacturing environments. Proven expertise in dossier preparation, CTD submissions, lifecycle CMC management, and handling global regulatory authority queries across international markets including Africa, MENA, GCC and Latam. Adept at bridging technical cross-functional teams (R&D, QA, QC, and Manufacturing) to ensure seamless compliance, project alignment, and launch-readiness.

Deeply aligned with the flat, communicative team cultures valued in Nordic workplaces, focusing on continuous learning, operational safety, and transparent compliance standards.

Senior Officer – Regulatory Affairs - Naprod Life Science Pvt. Ltd. - Andheri, Maharashtra, India

(2021-09)

A leading manufacturer specializing in oncology formulations and sterile injectable products.

• Compiled, drafted, and finalized multi-regional dossiers and lifecycle renewals for regulatory submissions. Managed CTD structures and customized layouts to satisfy strict country-specific entry guidelines.
• Systematically reviewed manufacturer master data profiles against cross-border regulatory criteria to verify document accuracy, safety completeness, and compliance profiles before formal submission.
• Evaluated Chemistry, Manufacturing, and Controls (CMC) engineering changes throughout product development lifecycles, matching changes to compliance updates.
• Submitted complex regional data through official regulatory platforms and proactively resolved authority-driven product queries within rigid corporate deadlines.
• Partnered transparently with R&D, QA, QC, and Manufacturing units to secure target compliance markers. Coordinated localized artwork creation and label updates for international market rollouts.
• Formulated technical responses to address and permanently close complex customer and global regulatory agency queries safely and promptly.

Officer – Microbiology (QC) - Dolce Pharmaceutical Pvt. Ltd. - Boisar, Maharashtra, India

(2020-06 - 2021-08)

A specialized manufacturer of formulations and quality oral solid dosage forms.

• Executed comprehensive microbial analysis on process water lines, incoming raw bulk materials, and finished goods. Led daily environmental monitoring validation programs.
• Authored clear laboratory SOPs and monitored strict sample handling protocols, maintaining strict alignment with cleanroom destruction safety procedures.
• Handled growth media preparation lines, strict culture bank maintenance, and ongoing real-time stability testing routines backed by traceable technical documentation.

Assistant Microbiologist – QC - Medibios Laboratory Ltd. - Boisar, Maharashtra, India

(2018-04 - 2020-06)

An established producer of therapeutic formulations, ointments, and active ingredients.

• Led routine microbial bioassays to establish correct potency profiles across various APIs, topical ointments, and finished medicine lines.
• Ran routine operational verification and physical calibration schedules for sensitive analytical lab instruments. Maintained organized stability study master calendars.
• Supervised laboratory environmental monitoring metrics, validation of sterilization autoclaving procedures, and strict bacterial culture preservation codes.

Junior Microbiologist – QC - Aarti Pharma lab Ltd. - Boisar, Maharashtra, India

(2016-06 - 2018-03)

A major Indian manufacturer of active pharmaceutical ingredients (APIs) and intermediates.

• Tested multi-stage process water networks and raw APIs to confirm structural alignment with international pharmacopeial standards.
• Operated Total Organic Carbon (TOC) monitoring analyzers to maintain objective data control on pure water distribution layouts.
• Maintained biological indicators, executed disinfectant sanitization verification tests, and prepped sterilized microbiological growth media.

Master of Science - Biotechnology - University of Mumbai (2010-05 - 2012-05)

Advanced Graduate Diploma - Regulatory Affairs - Institute of Pharmaceutical Management (IPM) (2024 - 2024)