Manager Regulatory Affairs
Manager Regulatory Affairs – Experis Switzerland
Objectives
* Responsible for supporting the regulatory activities related to the development, registration and life‑cycle management of vaccine candidates in Europe.
* Manages assigned regulatory projects including support of dossier/Marketing Authorization Application (MAA) submissions and life‑cycle management for vaccine candidates in the region.
* Ensures that all necessary applications are filed and maintained in compliance with applicable regulations.
* Responsible for regulatory oversight of assigned clinical trials conducted in the region.
* Provides regulatory oversight for assigned projects, focused on non‑clinical and clinical aspects of drug development/approval and associated regulations.
* Collaborates with all regulatory counterparts to ensure alignment and execution of the global regulatory strategy for the assigned projects.
* Passion for quality in all areas of responsibility.
* Leads and directs the work of others as part of a matrixed organization.
Accountabilities
* Close collaboration with the RAV Europe Region Head and Lead (and LOCs as applicable) to ensure alignment and regulatory strategy execution during file preparation, submission, review, approval and life‑cycle management.
* In cooperation with key stakeholders and RAV Europe Region Head/Lead (and LOCs as applicable), is responsible for overall content, management, compilation and timely availability of CTD Module 1 regulatory components to the assigned region/countries, ensuring filings meet local regulatory requirements. Has a quality focus so that submissions are right‑first‑time.
* Supports overall content and management of local regulatory components and filings e.g. MAA, MA variations. Contributes to content for local label development.
* Ensures compliance with both internal process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.
* Supports RAV Europe Region Head/Lead in the preparation of health authority interactions/meetings in the region as applicable for specified projects.
* Responsible for managing of submission components in the Electronic Document Management system (EDMS).
* Responsible for filing and archiving of regulatory relevant documentations/HA communications in compliance with SOPs.
Job Description
* Manages regulatory archives and maintains comprehensive chronology files for vaccine projects including, but not limited to, submission documents, contact reports, correspondence, and any other documentation pertinent to regulatory records in the EDMS.
* Supports tracking of regulatory activities and commitment in the region in systems as applicable.
* Actively participates as member of Global Regulatory Teams supporting products activities as assigned.
* Manages planning and execution of regulatory projects and initiatives as assigned.
Education, Behavioural Competencies and Skills
* Bachelor’s Degree preferred.
* A minimum of 6 years of pharmaceutical industry experience. This is inclusive of 3 years of regulatory experience or combination of 6 years regulatory and/or related experience in the vaccine area.
* Preferred experience in managing filings to EMA via Centralised Procedure resulting in first‑time approval; or managing multiple programs in closely related development area.
* Vaccines and/or biologics experience is essential.
* Participation in Global regulatory filing a plus.
* Understands and interprets scientific issues across projects as the issues relate to regulatory requirements and strategy.
* Strong in all basic skill sets such as oral and written communications (in English), managing and adhering to timelines, negotiation skills, integrity and adaptability.
* Exceptionally strong in working and communicating well with others including global, regional and local teams as well as cross‑functional teams; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies as applicable.
* Excellent organization skills and sound attention to detail.
* Team player.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Information Technology
Industries
Chemical Manufacturing
If you are interested to join a dynamic team, please send us your CV by clicking Apply.
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