Manager Regulatory Affairs Vaccine (RAV) Europe
Posted on Sep 25, 2019 by Harvey Nash IT Recruitment Switzerland
For our client in Zurich we are looking for Manager, Regulatory Affairs Vaccine (RAV) Europe for 12-month contract.
Job title: Manager, Regulatory Affairs Vaccine (RAV) Europe
Duration: 07/10/2019 to 06/10/2020
. 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 Company 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.
. 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 eg 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
. Actively participate as member of Global Regulatory Teams supporting products activities as assigned.
. Manages specific projects as assigned, eg regulatory activities related to
o EMA Transparency policy
o assigned clinical trials conducted in the region, such as Regulatory Affairs Vaccines TMF Oversight, and regulatory activities related to upload of study protocol and/or result information to EU databases/portal
. Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.
. Responsible for filing and archiving of regulatory relevant documentations/HA communications in compliance with SOPs.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
. BS, advanced scientific 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 skills 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.
. Team player
. Manual dexterity required to operate office equipment (ie computers, phones, etc.).
. Carrying, handling and reaching for objects.
. Ability to sit or stand for long periods of time while travelling.
. Willingness to travel to various meetings, including overnight trips. Some international travel may be required.
. Requires approximately 10 % travel.
For further details please contact: