Laetitia Misslin

Regulatory Affairs Manager – July 2019 to June 2020

Regulatory Affairs and Quality Pharmacist – March 2027 to June 2019

• Active role in regulatory strategy development
• CMC writing (injectable and tablet forms)
• Regulatory activities (Marketing Authorisations, variations, life cycle, renewals…) for European countries (national, MRP and CP) and for export countries
• New Marketing Authorisation Application through the centralised procedure for an ODD
• Manage timely and efficiently the Response to CMC questions from National Health Authorities
• Lead contact with external Alliance partners and CMOs ensuring aligned strategy and optimised communication.
  Team management
• Project management to achieve the company's objectives
• Change control / SOPs / CAPA/ Deviations

Medical Devices

• Review of Master Batch Record
• CAPA/Deviation
• Labelling
• Change control

employed by Blue-Reg PharmaConsult

In charge of registration activities for the ophthalmology and neurology portfolios

• Control of promotional material (medical devices: fillers and breast implants)
• French DMOS regulation (French anti-benefits regulations to control the relationship between the pharmaceutical industry and healthcare professional)

Virology, Cardiology and Oncology portfolios

• Preparation, submission and follow-up of new Clinical Trial Application (CTA), and amendments in relationship with the competent authorities
• Validation of labeling and variations in centralized and mutual recognition procedure
• Compassionate Use (Temporary Authorization for Use)
• Regulatory and competitive intelligence

Nutrition and Intravenous Therapy Portfolios

• Variations in national and European procedures, Artworks validation, CMC writing, PSUR submission
• Management of authorization for import, Control of promotional material
• Regulatory and competitive intelligence

• Evaluation of SME status application and Regulatory assistance to SMEs
• Participation in the development of a public database for SMEs