Stéphanie Baqué

• Post market activities, :

-Maintenance and compliance of existing Marketing Authorizations in EU/CH (labeling and CMC variations)
- Responsible for supporting Clinical & Pre-clinical Modules activities WW (variations, HAQ, new registrations)
- CCDS update

- Support to 3 Scientific Advises with EMA

- Promotional material : support team for material development and validation

• Development activities: Phase I and II projects, EU/US

- CTA preparation and submission

- Substantial and non substantial amendments

- PIP/PSP strategy definition

• Regulatory Affairs Representative in relevant Project teams
• Regulatory Intelligence
• CMRST Lead

Therapeutic area: Pain Relief

Key markets: EU, Australia, South Est Asia

• Regulatory strategy development and implementation for Innovation projects and business continuity program's

a Regulatory Affairs Awards in 2020 for smart regulatory risk taken

• GRA representative in project team: regulatory assessment acting as key business enabler
• Regulatory activities for a brand portfolio: labeling, variations, new registrations in all regions WW
• CTA coordination
• Regulatory Compliance activities within SOP committee
• Mentoring of a junior team member
• Regulatory assessment of promotional material
• Regulatory lead on PRAC art 31 referral

- Single point of contact with EMA project manager

- In collaboration with SMEs preparation and submission of the regulatory packages

- team preparation and presentation at ad-hoc expert group meeting and CHMP meeting for Oral Explanation at EMA.

Therapeutic area: Dermatology, Gastro-intestinal

Key Markets: EU, China

• New registrations (incl. China), Rx to OTC switches & life-cycle maintenance activities for more than 300 MAs
• CTA preparation and submission in China
• Regulatory evaluation of new in-licensing opportunity and due diligences
• Regulatory representative in Project Teams for assigned projects
• Development and implementation of regulatory strategies
• Risk assessment for life cycle activities and projects
• Medical Device class II registration project in EU and Russia
• Contribution to GRA process enhancement
• Coaching of juniors team member.

Therapeutic area: Smoking cessation, Gastro-intestinal

Key markets: EU, US

• Life-cycle maintenance activities WW
• New registrations applications (MRP,DCP) and Rx to OTC switches in EU and ROW
• Leading Global Regulatory Affairs sub-teams (labeling/CMC/RegOps)
• Regulatory Lead for assigned brands:

- RA representative in project teams

- Lead of GRA sub-teams (labeling/CMC/RegOps)

• CTA application preparation, coordination and submission
• Scientific Advice Meeting type D with FDA.
• IND preparation and submission

Therapeutic area: Fertility

Key markets: EU, Russia

• Life cycle maintenance activities in EU: (products registered via CP, MRP, NP): CMC and labeling variations, FUM, PSUR, ASR
• Geo-expansions: preparation and dispatch of regulatory packages for ICH countries new registration submissions
• Clinical trial: Review of Clinical trials protocols and CTAs preparation and submission for a phase IV study in EU and Russia

Therapeutic area: Immunology, Infectious Diseases and Rheumatology

• Support to regulatory development activities for a medicinal product in Phase 3 : CTA and IND preparation, SmPC drafting, preparation and coordination of scientific advices with EMA,.
• Post-approval activities: in charge of the preparation and submission in EU of the type I/II variations, FUMs, PSURs, PIP deferral for MRP and CP registered products
• Involved in Regulatory strategy definition,in interaction with Health Authorities, local affiliates and CROs.

• Clinical pharmacy, Pharmacovigilance, Clinical trials

• Market analysis of cardiovascular drugs in Baltic States and CIS countries