Bharathi Chittharanjan

Accomplished Regulatory Affairs Specialist with expertise in FDA regulations and global compliance. At Dossier Solutions, accelerated product market entry by leading high-quality submissions. Skilled in cross-functional team leadership and CAPA management, enhancing productivity and efficiency. Proven track record in optimizing processes and mentoring teams, ensuring adherence to international standards and regulatory requirements.

Experienced with regulatory compliance, documentation, and submissions. Utilizes comprehensive knowledge of regulatory landscapes to streamline approval processes. Strong understanding of industry regulations and collaborative project management.

• As a gate keeper in my QA role at P&G, I reviewed, approved and released upper respiratory healthcare OTC products for consumer testing and launch, ensuring that the products and robust processes met rigorous high global quality standards. As a QA Auditor, I have assessed, qualified and upgraded a contractor laboratory to global ISO Standards by regular repeated audits and feedbacks. I was pivotal in implementing, maintaining and sustaining the highest quality standards that led to PDD receiving the 3rd Pinnacle Award for achieving very high rating of 92% QA Capability in the Corporate Audit.
• As Regulatory Affairs executive, my assistance in preparation/reviewal of country-specific regulatory documents for many drugs was instrumental for pharma companies in securing approvals and successfully submitting applications to authorities for product registration in different export markets.
• As an innovative trainer in Sartorius, I developed new SOP for training as per ISO requirements, created PowerPoint presentation, prepared questionnaire/agenda, co-ordinated training programs on Sartorius laboratory products and production items, imparted training for customers as well as for building up the capabilities of the internal sales/marketing personnel. I set up labs for chemical and microbiological testing for company products including Sartorius balance/other instruments/equipment, ensured calibration/documentation/lab note books and readied the facilities for audit.
• As scientific officer in HMR, I was a key player in contributing to the identification and characterization of a new therapeutic lead from a microbial broth, a very potent G-6-P Translocase Inhibitor that was patented by the parent company Hoechst AG.

• Certificate abridged courses from Biopharma Institute – Introduction to GMP, GMP Awareness for food industry (Feb and Mar 2025)