Kamlesh Sharma Email & Phone Number

As a seasoned Global Regulatory Affairs Professional with nearly **12 years of industrial experience**, I specialize in navigating the complex landscape of regulatory affairs. My focus lies in ensuring compliance and successful submissions to regulatory bodies worldwide, including the US FDA, EU, and other regions.## Professional Journey**Current Role: Principal Regulatory Affairs Specialist at PPD (Thermo Fisher Scientific)**- **Tenure**: 6 years- **Responsibilities**: - **Life Cycle Maintenance**: Managing regulatory aspects throughout product life cycles. - **CMC Authoring**: Crafting Chemistry, Manufacturing, and Controls (CMC) documentation. - **Regulatory Operations**: Streamlining processes for efficient submissions. - **Submission Planning and Management**: Orchestrating successful regulatory submissions.**Previous Experience:**1. **Fresenius Kabi** - **Tenure**: 3.9 years - **Focus**: Expertise in life cycle maintenance and CMC authoring.2. **Biocon Biopharmaceuticals** - **Tenure**: 1.5 years - **Expertise**: Specialized in biosimilars for the Indian market, covering pre-clinical, clinical, and initial Marketing Authorization Applications (MAAs).3. **PharmaLeaf India Private Limited** - **Tenure**: 6 months - **Role**: Conducted literature searches and compiled dossiers.**Diverse Exposure:**- **Molecule Variety**: Proficient in both small molecules and large molecules.- **Global Submissions**: Skilled in preparing Module 1 documents and Module 2/3 CMC authoring for global submissions.- **End-to-End Management**: - **Pre-Clinical Submissions**: Ensured regulatory compliance during pre-clinical phases. - **Initial MAAs**: Successfully navigated initial Marketing Authorization Applications. - **Post-Marketing Activities**: Managed renewals, variations, notifications, annual reports, site registrations, and tender requests. - **Query Responses**: Prepared and submitted timely responses to health authorities.**Software and Tools:**- **eCTD Manager**- **VeeVa Vault**- **RIMS**- **ESG**- **CESP****Key Skills:**- **Effective Communication**: Excellent presentation skills and clear communication.- **Resilience**: Thrive under pressure and adapt to dynamic regulatory environments.- **Negotiation**: Skilled in advocating for regulatory compliance.- **Collaboration**: Successfully coordinate with diverse teams.**Contact Information:**Feel free to reach out to me at **kamlesshhh@gmail.com** or call me at **+91-9560495551** for any career-related opportunities. Let's connect! 🤝