Regulatory Affairs Vaccine Manager
An internationally leading pharmaceutical company is seeking to recruit a Regulatory Affairs Vaccine Manager to their office in Switzerland. Specialising in multiple therapy areas, the company boasts a superb pipeline with products that include treatments for diabetes, cancer and asthma. This is an exciting opportunity to work with a company that operates in over 90 countries across the globe.
- Responsible for supporting the regulatory activities related to the development, registration, and life cycle management of vaccine candidates in Europe.
- Manage assigned regulatory projects including support of dossier/Marketing Authorization Application (MAA) submissions and life cycle management for vaccine candidates in the region.
- Ensure 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.
- Provide regulatory oversight for assigned projects, focused on non-clinical and clinical aspects of drug development/approval and associated regulations.
- Collaborate with all regulatory counterparts to ensure the alignment and execution of the global regulatory strategy for the assigned projects.
- Leads and directs the work of others as part of a matrixed organization.
- Oversee 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.
- Cooperate 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.
- Support the overall content and management of local regulatory components and filings e.g. MAA, MA variations; contributes to content for local label development.
- Ensure 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.
- Support 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, e.g. regulatory activities related to
- EMA Transparency policy
- 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.
- Filing and archiving of regulatory relevant documentations/HA communications in compliance with company SOPs.
Skills and Requirements:
- 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.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 078 9542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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