Pranjil Kulshrestha
Regulatory Affairs Professional with Global Experience | Expertise in Dossier Preparation, Veeva RIM, SAP & International Labelling Compliance | Food, Flavour, Cosmetic & Pharma Industry | Global RA Strategy & LCM
- Role
- Specialist at DöhlerGroup
- Location
- Pune District, MH, IN
- LinkedIn followers
- 500 followers
About Pranjil Kulshrestha
As a Bio-technologist and possessing around 10 years of rich experience in the field of…
Experience
Specialist
Nov 2023 — Present · Pune, IN
Responsibilities: Global Regulatory Affairs (GBS)1. Support Global Regulatory & Product Documentation team (Germany HQ) by addressing customer regulatory requests through the WeLead ticketing system.2. Monitor and implement compliance with global food regulations and legislation for both internal and external documentation.3. Collaborate with Quality Assurance and R&D teams to resolve customer queries related to product compliance and specifications.4. Work closely with Europe and Non-Europe Regulatory Affairs teams to meet international regulatory requirements and guidelines.5. Checking & Managing implementation/compliance with food /regulation legislation.6. Manage internal quality certifications (Halal, Kosher, Organic) and regulatory documents through the Document Management System (DMS).7. Maintain raw material data in the CG02 substance database (SAP) for traceability and compliance.8. Review B2B and B2C product formulations/recipes for alignment with country-specific regulatory requirements.9. Checking Label compliance of B2C products and providing customer specific label support to B2B customers.10. Led and mentored junior team members, ensuring knowledge transfer and consistent execution of regulatory documentation processes.11. Coordinated cross-functional collaboration between Regulatory, Quality, Internal Sales support and R&D teams, ensuring timely resolution of customer queries and efficient workflow management across global stakeholders.12. Contributed to process improvements for document handling, request triaging, and regulatory workflow optimization.
Education
Hindustan College of science and technology
Bachelor of Technology (B.Tech.), Biotechnology
2009 — 2013
Madhav Institute of Technology and Science, Gwalior
Master of technology's degree with honours (M.Tech), Biotechnology
2013 — 2015
Ramakrishna Mission Vidyamandira
High School Certificate and Senior Secondary Certificate, High School/Secondary Certificate Programs
2006 — 2009
Skills
- • Sds-Page.
- Microbiology
- Microsoft Word
- • Clone Selection.
- Life Sciences
- Team Management
- Powerpoint
- Microsoft Excel
- Cell Culture
- Bioinformatics
- Information Gathering
- Sds-Page
- • Proteinometer.
- Molecular Biology
- Food Regulatory
- Scientific Writing
- Computer Proficiency
- Pcr
- • Laminar Air Flow Unit (Lafu).
- • Polymerase Chain Reaction
- Quality Control
- Gmp
- • Gel Chromatography.
- C
- • Electrophoresis.
- Regulatory Affairs
- • Southern Blotting.
- Biotechnology
- C++
- • Ultra-Centrifuge.
- Cell Biology
- Research
- Biochemistry
- Glp Requirements
- Microsoft Office
- • Table Top Centrifuge.
- • Dialysis.
- Attention to Detail
- • Bead Mill.
- Probiotic Regulatory
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