- The Regulatory Affairs Registration Manager is responsible for the maintenance of the worldwide products licenses Organize investigator’s start-up meeting and study site initiation meetings.
- Coordinate and interact with the internal stakeholders (labeling/safety/epidemiology/clinical and technical Experts) for the preparation of the documents part of the regulatory dossiers/data-packages in order to meet the submission timelines
- Ensure that all regulatory aspects on the product safety/Pharmacovigilance and commitments/obligations to Authorities are closely monitored and full filled
- Prepare cover letters, application forms, letters of intent, letters to request deadline extensions etc. Strong involvement in CTD Module 1
- Exhibit a very good understanding and ensure alignment with regulatory legislation/guidelines, particularly relating to administrative and procedural aspects
- Coordinate, prioritize and plan all the registration activities for the projects within area of responsibility to ansure deadlines are met
- Maintain close contacts with the Local Operating Compagnes’s (LOC’s) to ensure shared objectives are achieved
- Ensure the tracking of relevant correspondence with Authorities and Company Local
- Communicate with external regulators on specific enquiries
- Communicate regulatory updated information to internal stakeholders
- Participate in (or lead) the development of the SOPs and guidelines, be trained, be a good relay to develop the awareness within the team, act sometimes as a trainer and follow Company procedures appropriately.
- Participate in (or lead) the Regulatory Project Team and gives feedback on their specific areas of expertise
- Understanding of international Regulatory Affairs environment
- Understanding of the ethical, regulatory, compliance and legal framework related to the delivery of promotional materials to be used internally and externally
- Fluency in English and French