Carole Abitan PharmD

•Project Leadership: Spearheaded the implementation of a new Regulatory Information Management System (RIMS), overseeing the end-to-end process from defining project scope to operationalizing the RIM Strategic Plan. •Strategic Planning: Played a pivotal role in formulating the planning function strategy, contributing to the overall success of regulatory projects.

•Strategic Planning and Implementation: Spearheaded the creation of a comprehensive Quality Documents (QD) plan for IDMP implementation based on the thorough assessment conducted by the Regulatory Affairs Consultant. •Collaboration and Leadership: Fostered a strong collaboration with Subject Matter Experts (SMEs), ensuring that processes align with Business Needs through the facilitation of dedicated Quality Documents committees.

Responsible for pharmaceutical products regulatory life cycle management in the local affiliate/market. Organize regulatory information and track submissions, support compilation of dossier applications, coordinate certificates and sample issues, maintain RIM information. Duties & Responsibilities Collect and coordinate information and compile documentation for submission to regulatory agencies or to commercial partners. Timely compile materials for license renewals, updates and registrations Maintain regulatory files/database and chronologies in good order. Maintain system for tracking changes, in documents submitted to agencies or partners. Coordinate the regulatory reviews of customer complaints and define the regulatory reportability. Coordinate samples and certificate.

­Acts as a Regulatory Team Leader on complex projects, which may include technical writing for a stand-alone project with guidance from senior staff as appropriate. ­Compliance verification of texts approved by UK authorities(MHRA…) ­In Contact with MHRA, monitoring of correction actions, verification of approval, communication of corrected mock-ups to production services ­Revision of SPC and PIL on MHRA/EMC website ­Acts as a Regulatory Advisor on small, straightforward regulatory projects ­Ability to administratively or technically / scientifically review core scientific documentation and feedback gap analysis to customer.

­ Delivery and control of prescriptions, extensive sales experience, advice, para, dietetics, ­ Good knowledge in aromatherapy, homeopathy and micronutrition, ­ Good relationship, dynamic and team spirit Strong verbal & written communication skills

­Registration: Ensure the creation, monitoring and maintenance of marketing authorization files in France, for submission to health authorities ­Advertising Communication: Participates in compliance verification, validation of promotional, institutional and environmental elements, and deposit of promotional elements with health authorities. ­Packaging: Follow the control and modifications of the packaging of the Mother House products. ­Quality assurance: Participates in the drafting and updating of procedures related to pharmaceutical operations, specifications and supervision of subcontractors for pharmaceutical operations. Monitor pharmaceutical claims, batches and simulate batch recalls, and monitor quality indicators ­Medical Visit Charter: Participate in maintaining certification ­Monitor compliance verification and validation of items for Medical Delegates

Review of all Phase 2 studies submitted and completed (or ongoing) ­Preparation and follow-up of applications for the authorization of multi-center European clinical trials in phase 3 according to the regulations in force (CTA) ­Prepares and maintains core CTA for clinical trials in accordance with applicable regulatory requirements. ­Responsible for activities relating to the submission to the competent authorities of the amended application dossiers in France and England ­Ensure traceability and archiving of regulatory documents

Securing the drug circuit in the gynecological-maternity department (audit) ­Implementation of an audit, and development of an audit grid, preparation of the audit report and implementation of corrective measures ­Contribution to the treatment evaluation of patients with specialist doctors and medical students.