Akhilesh Dubey
Regulatory Affairs
Gurgaon
Summary
Passionate about making a significant impact in the cosmetics & pharmaceuticals sector, eager to leverage expertise in business development, formulation development, and regulatory affairs. Strong belief in the power of strategic thinking and innovation, committed to driving growth and success for the organization. Goal is to contribute meaningfully to the company's objectives and achieve mutual professional and financial success.
Overview
15
15
years of professional experience
8
8
years of post-secondary education
2
2
Languages
Work History
Manager Regulatory & Compliance
QUEST RETAIL PVT LTD (The Body Shop India)
08.2022 - Current
- Registration of International Cosmetics Brands such as The Body Shop, Kylie Cosmetics, Max Factor, Anastasia Beverly Hills, Juice Beauty, Kiehl's, AVON Beauty, Neal's Yard Remedies, Bio Miracle, Freeman Beauty in India, Sri Lanka and Bangladesh.
- Review of Labeling
- CMC Review/Writing
- FDA/CDSCO Co-ordination
- Manage & Co-ordination with International team and supplier.
- Maintain Approvals/Licenses
- Co-ordination with MCD, Legal Metrology Department
Manager Regulatory & Compliance
KIKO MILANO (KIKO COSMETICS RETAIL PVT LTD)
10.2021 - 08.2022
- Registration of New Launches, Collections and Base line make up cosmetics, Skin Care products in India within stipulated time-bound manner.
- Review of all technical documents, CMC (Chemistry, Manufacturing & Control) scrutiny.
- Co-ordination KIKO Spa team, Italy to plan timely registration in India.
- Updation on Regulatory guidance to Global team and supplier.
- Weekly co-ordination with CDSCO- Central Drugs Standard Control Organization for Brand Registration in India.
- Responsibly handled to MCD Trade and Advertisement Licenses and Legal Metrology and packaging commodities matters.
Regulatory Affairs Lead
OZONE PHARMCEUTICALS LTD.
10.2018 - 10.2021
- Re-association with Ozone Group of companies as Regulatory Affairs Lead for domestic and ROW product registration for Cosmetics, Ayurvedics and Nutraceutical Products.
- Handling New Product/Formulation Development (NPD/FRD) being part of R&D Dept.
- Expertise in Tech Transfer from R&D to Production level.
- Review/writing of Product Labels.
- Registration of International Cosmetics Brands in India (Pevonia, Novex).
BULAT PHARMACEUTICAL PVT. LTD.
11.2017 - 09.2018
- Company Overview: is a subsidiary of Shandong Sihuan Pharmaceutical Co. Ltd. China.
- Leads to Regulatory Department for Registration of Cosmetics, APIs and Formulation for Domestic (India) and International Markets.
- Coordinating with various outsourced parties to obtain Local Business Licenses for Business Development.
- Preparation & review to all CMC documents and gentle co-ordination with Product Manufacturer in case of Loan License/CMS Module.
- Patent Analysis and Online Market Research for targeted countries to initiate International Business.
- Is a subsidiary of Shandong Sihuan Pharmaceutical Co. Ltd. China.
OZONE PHARMCEUTICALS LTD
01.2011 - 10.2017
- Co-ordination with State Licensing Authority to obtain Cosmetics and Ayurvedic's product licenses.
- Gentle co-ordination with Raw Materials Manufacturers/Supplier to compile API/excipients information.
- Review and preparation MSDS/Technical (Material Safety Data Sheet) data sheet of product.
- Coordination with Govt. dept. FDA, CDSCO and GS1 India regarding barcode implementation and applications.
- Review and Approval of Products Artwork (Packaging) for New Products Development (Labeling of Products).
- Preparation of Registration Dossiers for Cosmetics and Pharmaceuticals as per ACTD, CTD and per Country Specific Guidelines.
- Region and Countries worked for :(ASEAN, EU, SOUTH ASIAN, NORTH AMERICA, AFRICAN)
- Myanmar, Philippines, Cambodia, Vietnam, Thailand, Indonesia & Laos
- Armenia (EU)
- Sri Lanka, Maldives, Nepal and Bhutan
- Canada
- Nigeria, Ghana, Tanzania, Mozambique, Swaziland, Cameroon etc.
- Reviews of CMC (Chemistry, Manufacturing & Control) Documents.
DHARMANI HERBS INDIA
10.2010 - 01.2011
- Documentation (SOP- Standard Operating Procedure, BMR-Batch Manufacturing Record of Product)
- Regulatory Affairs (Preparation of Herbal Products Dossiers) Business Data Management and Forecast
Education
High School -
U.P. Board
Intermediate - undefined
U.P. Board
Bachelor of Science - undefined
V.B.S. Purvanchal University
01.2007 - 01.2010
Master of Science - undefined
J.S. University
Shikohabad, U.P. 01.2020 - 01.2021
Lead Auditor Food Safety Management System - Auditing
Exemplar Global
Australia 04.2001 -
Skills
Strategic team guidance
Process optimization expertise
Goal-oriented planning
Analytical decision-making
Accomplishments
- DCA: Diploma in Computer Application
- Six Sigma Yellow Belt
- FDA-Human Drug Review & Approval Basics
Disclaimer
I hereby declare that the above details are true and correct to the best of my knowledge.,
New Delhi.
Akhilesh Dubey
May, 2025.
Personal Information
- Hobbies: Music, Dance
- Father's Name: Sri Jai Prakash Dubey
- Date of Birth: 07/17/90
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Timeline
Manager Regulatory & Compliance
QUEST RETAIL PVT LTD (The Body Shop India)
08.2022 - Current
Manager Regulatory & Compliance
KIKO MILANO (KIKO COSMETICS RETAIL PVT LTD)
10.2021 - 08.2022
Master of Science - undefined
J.S. University
01.2020 - 01.2021
Regulatory Affairs Lead
OZONE PHARMCEUTICALS LTD.
10.2018 - 10.2021
BULAT PHARMACEUTICAL PVT. LTD.
11.2017 - 09.2018
OZONE PHARMCEUTICALS LTD
01.2011 - 10.2017
DHARMANI HERBS INDIA
10.2010 - 01.2011
Bachelor of Science - undefined
V.B.S. Purvanchal University
01.2007 - 01.2010
Lead Auditor Food Safety Management System - Auditing
Exemplar Global
04.2001 -
Intermediate - undefined
U.P. Board
High School -
U.P. Board
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