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Regulatory Affairs - Vaccines, Europe - Assoc. Director

Zurich, Switzerland

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Regulatory Affairs - Vaccines, Europe - Assoc. Director

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Job ID R0019171 Date posted 04/24/2020 Location Zurich, Switzerland

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Job Description

Regulatory Affairs - Vaccines, Europe  - Assoc. Director

Reports To:

Head Regulatory Affairs Vaccines (RAV) Europe

Location:

Zurich

OBJECTIVES:

·       Responsible for regulatory activities supporting the development and registration of vaccine candidates in Europe.

·       Manages regulatory projects including Marketing Authorization Application (MAA) submissions for multiple vaccine candidates

·       Ensures that all necessary applications are filed and maintained in compliance with applicable regulations.

·       Leads and directs the work of others as part of a matrixed organization.

·       Provides regulatory oversight for assigned projects, focused on non-clinical and clinical aspects of drug development/approval and associated regulations.

·       Collaborates with all Takeda regulatory counterparts to ensure a global regulatory alignment for all projects within area of responsibility.


ACCOUNTABILITIES:

·       Co-ordinates and is accountable for all Health Authority submissions and approvals within area of responsibility. Has a quality focus so that submissions are right-first-time.

·       Acts as primary regulatory authority contact for projects of responsibility.

·       Coordinates interactions with and submissions to EMA. Communicates effectively the outcome of Health Authority interactions and provides analyses of potential impact.  

·       Ensures compliance with both internal Takeda process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.

·       Act as EU regulatory content and procedural subject matter expert to internal stakeholders on matters related to regulatory affairs activities in the EU and other European countries. Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.

·       Accountable for overall content and management of local regulatory components and filings e.g. MAA, MA variations. Contribute to overall strategy and content for local label development.

·       Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.

·       Actively participate as member of Global Regulatory Teams supporting products.

·       Responsible for EU specific documentation supporting development and maintenance of products and ensuring filings meet local regulatory requirements.

·       Leads and manages health authority meetings as applicable for specified projects.

·       Manages specific projects as assigned, e.g. activities related to Regulatory Affairs Vaccines TMF Oversight.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

·       BS, advanced scientific degree preferred.

·       A minimum of 7 years of pharmaceutical industry experience. This is inclusive of 5 years of regulatory experience or combination of 7 years regulatory and/or related experience in the vaccine area.

·       Vaccines and/or biologics experience is essential.

·       Preferred experience in managing filings to EMA via Centralized Procedure resulting in first-time approval; or managing multiple programs in closely related development area.

·       Relies on extensive experience and judgment to plan and accomplish goals.

·       Understands and interprets complex scientific issues across projects and area(s) of responsibility as the issues relate to regulatory requirements and strategy.

·       Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.

·       Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

·       Exceptionally strong in the following areas: working well with others including on cross-functional teams and communication with leadership.

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0019171

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