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
Manufacturing & ProductionView LinkedIn profile

About Pranjil Kulshrestha

As a Bio-technologist and possessing around 10 years of rich experience in the field of…

Experience

  1. Specialist

    DöhlerGroup

    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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Pranjil Kulshrestha — Specialist at DöhlerGroup in Pune District, MH, IN | Unifers