Murali Krishna
Regulatory and Quality Expert - Life Science Industry (Pharma & Personal Care Industry). I Authoring Dossier and Product Compliance to successfully launch the products globally.I ANDA\'s, DMF, PIF and Techincal Files.
- Role
- Regulatory Head at Positivity
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Murali Krishna
With 20 years of experience in the Pharma and Personal care Industry, I Worked with MNCs…
Experience
Regulatory Head
May 2021 — Present · Hyderabad, IN
Spearheaded regulatory compliance efforts for a diverse portfolio of personal care products, ensuring adherence to global regulations and standards.• Managed registration processes with regulated and semi-regulated health authorities worldwide, facilitating market access for products. US FDA – MOCRA, OTC Products, EU Directive 1223/2009, Saudi KSFDA, Health Canada, Australia TGA and NICNAS, Cosmetic Rule 2020, Drugs and Cosmetic Act, Indonesia BPOM, Thailand FDA, Singapore HAS, Malaysia NPRA, Oman MOH, Kuwait SFDA, Duabi Municipality Montaji Portal, ESMA.• Consistently stay abreast of the latest regulatory developments and promptly implement new regulations to ensure compliance.• Conducted safety assessments of cosmetic and personal care products, implementing risk mitigation strategies and ensuring consumer safety.• Deep Understanding of Cosmetic ingredients and its regulatory requirement• Led interactions with conformity bodies such as SGS, TUV, Cotecna and Intertek to facilitate
Education
AV College Hyderabad
B.Sc, Industrial Chemistry
1999 — 2001
Moulana Azad college
Master's degree, Industrial chemistry
2001 — 2003
Skills
- Change Control
- Oncology
- Protocol
- Chemistry
- Cleaning Validation
- Lc-Ms
- Quality System
- Life Sciences
- Dissolution
- Formulation
- Generic Programming
- Standard Operating Procedure (Sop)
- Analytical Method Validation
- Technology Transfer
- Pharmaceutical Industry
- Sop
- Fda
- Chromatography
- Anda
- U.s. Food and Drug Administration (Fda)
- Gas Chromatography
- Validation
- Computer System Validation
- Quality Assurance
- Corrective and Preventive Action (Capa)
- R&D
- Method Development
- CRO Management
- High-Performance Liquid Chromatography (Hplc)
- Quality Control
- Gmp
- Pharmacology
- Capa
- Good Laboratory Practice (Glp)
- Lims
- Regulatory Submissions
- Regulatory Requirements
- Hplc
- Glp
- Quality by Design
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