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Léa CallyLC

Léa Cally

R&D and Regulatory Affairs Cosmetic Management

€800/day
1 project
Paris, FR
8-15 years

Average response time: 1 hour

Freelancer profile translated to English.
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About Léa

Doctor of Pharmacy, cosmetologist, trilingual, multicultural and versatile, with a strong ability to adapt to projects and different company profiles.

I place at your disposal the fruits of my many years of study and my 20 years of rich and productive professional life, which have allowed me to acquire remarkable technical skills as well as appreciable human qualities.

These skills, combined with my passion for cosmetics and my determination to succeed, make me the most suitable person to lead your development project, in order to design quality, high-performance and safe products that can retain your customers.

The tasks I can handle throughout the development process are as follows:

Phase I: Pre-development Stage
  • Dermo-cosmetic studies of the project
  • Preparation of the ingredient blacklist
  • Research and selection of active ingredients
  • Assistance with fragrance creation
  • Writing a detailed creative brief

Phase II: Formulation Management
  • Monitoring formulation trials
  • Pre-safety assessment
  • Sensory evaluation of formulation trials
  • Monitoring and validation of pre-tests
  • Evaluation of microbiological sensitivity and stability
  • Validation of industrial pilot

Phase III: Monitoring and Validation of Formula Evaluation Tests
  • Stability study
  • Safety study
  • Efficacy study
  • Calculation of theoretical PAO
  • Actual PAO

Phase IV: Regulatory Affairs
  • Product Information File (PIF)
  • Safety assessment (toxicological study)
  • Notification
  • Validation of final artwork approval
  • Certification
  • Certificate of Free Sale (CFS)
  • Recommendation

Phase V: Industrialization
  • Validation of batch release
  • Non-conformity management
  • Quality audit

Phase VI: Commercialization
  • Export assistance (obtaining the certificate of conformity): Saudi Arabia, Egypt
  • Arabic

    Native or bilingual

  • French

    Native or bilingual

  • English

    Fluent

Remote only
Primarily works remotely

Experience

  • ICHC-Consult
    Consultant in R&D and Regulatory Affairs
    FASHION AND COSMETICS
    December 2020 - Today (5 years and 6 months)
    Saint-Maur-des-Fossés, France
    Management of cosmetic product development projects and subcontractor management

    R&D:

    • Development specifications, Active ingredient selection, Fragrance creation, Development process management, Test monitoring, ...
    Regulatory Affairs:
    • Regulatory file (PIF), Regulatory compliance (labeling, instructions, communication materials).
    • Certification: Cosmos, Halal, CFS, ...
    • CPNP Notification.
    Toxicology:
    • Safety assessment of cosmetic products.
    Quality:
    • Quality audits of subcontractors according to ISO 22716 standard.
  • Laboratoires Arcana
    Head of R&D, Quality Assurance, and Regulatory Affairs
    FASHION AND COSMETICS
    September 2016 - January 2020 (3 years and 4 months)
    Neuilly-sur-Seine, France
    Management of product development (natural and organic):
    • Specifications
    • Active ingredient research
    • Formulation
    • Tests,
    • Clinical evaluation,
    • Scale-up to industrial level,
    • Scientific communication dossier

    Quality Assurance
    • Release of subcontracted batches (production and packaging)
    • Non-conformity/CAPA management
    • Quality audit
    • Creation and development of documentation

    Regulatory Affairs
    • Regulatory file/PIF
    • Notification
    • Cosmos Certification
    • International Registration
    • Regulatory Watch
  • Sarrag Pharma
    Head of R&D and Quality
    PHARMACEUTICALS INDUSTRY
    February 2013 - March 2015 (2 years and 2 months)
    Lattaquié, Syria
    Participation in the launch of a cosmetic product line.
    • R&D project management: formulation, testing, and regulatory.
    • Implementation of a quality assurance program in compliance with ISO 22716 and ISO 9001 standards
    • Release of raw material, active ingredient, bulk, and finished product batches.
    • Non-conformity management and continuous improvement

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Education

  • Inter-University Diploma (DIU): Medical Toxicology
    Faculty of Medicine - University of Lille
    2023
  • Master 2: Quality of Health Products, Cosmetology track
    Faculty of Pharmacy, University of Paris V
    2016
    Formulation, Règlementation, Assurance Qualité des Produits Cosmétique

Skill set (15)

Categories

  • Other