Regulatory Affairs Registration Manager

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Description de l'emploi

Purpose of the Mission (project & department description)

The Regulatory Affairs Registration Manager is responsible for the maintenance of the worldwide vaccine licences. by ensuring the planning/dispatch/submission/follow-up/approval of data-packages due to Regulatory Authorities: Variations, Commitments, Questions & Answers, PSURs/PBRERs, Risk Management Plans (RMPs), Renewals, Articles 46, Updated files, WHO Annual Reports, New Dossier requests etc …

Primary Tasks & Responsibilities

The role has the following responsibilities:

• 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/Pharmaco-vigilance and commitments/obligations to Authorities are closely monitored and fulfilled
• 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 ensure 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 the Local Operating Companies (LOCs): in archiving database (TRAC-IT)

Communicate with relevant parties:

• 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
• Be responsible for Vaccine Registration activities of one or several projects
• Identify key issues on registration activities that could prevent achieving objectives and pro-actively propose solutions

Profil

Knowledge/skills

• Knowledge of Regulatory legislation in at least one geographic area
• Basic understanding of biologicals/vaccines

Soft skills

• Team spirit, flexibility and accountability, very well organized, good relationships, able to work in multi-cultural and multi-disciplinary environment, discipline
• Integrity
• Analytical capacity
• Good organizational skills
• Flexible work approach; enjoys a varied working day
• Teamwork and collaboration
• Customer oriented
• Can work under stress and to deadlines
• An eye for detail

Experience

• Experience in the pharmaceutical industry; this should also include RA experience

Education, Methodology & Certification Requirements

• University degree (preferably biological/chemical), advanced degree is often preferred.

ICT Skills (software, operating systems, hardware, etc.)

• Microsoft Word
• PowerPoint
• Excel

Language Proficiency Requirements

• English - Fluent