Regulatory Strategy Objectives::
* Responsible for regulatory activities supporting the development of vaccine candidates
* Manages regulatory projects and submissions for vaccine candidates
* Ensures that all necessary applications are filed and maintained in compliance with applicable regulations.
* Provides regulatory oversight for assigned projects, focused on non-clinical and clinical, and CMC aspects of drug development and associated regulations.
* Leads and directs the work of others as part of a matrixedorganization
* Collaborates with all regulatory counterparts to ensure a global regulatory alignment for all projects within area of responsibility
* Provides global CMC regulatory program support to vaccine programs in various stages of development.
* 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.
* Coordinates interactions with and submissions to FDA. Communicates effectively the outcome of Health Authority interactions and provides analyses of potential impact.
* Ensures compliance with both internal company process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.
* Act as US regulatory content and procedural subject matter expert to internal stakeholders on matters related to regulatory affairs activities in the US and Canada. Provides a regulatory strategic focus on all aspects of drug development and associated regulations.
* Accountable for overall content and management of local regulatory components and filings i.e. BLAs, INDs . 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 US specific documentation supporting development and maintenance of products and ensuring filings meet local regulatory requirements.
* Manages health authority meeting preparation as applicable for specified projects.
* Prepares and manages regulatory submissions for assigned vaccines in various phases of development.
* Supports regulatory compliance assessment with respect to filing requirements for assigned vaccines throughout development.
* Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements
* Ensures project team colleagues, line management, and key stakeholders are apprised of risks that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
* Evaluates change controls for regulatory impact and filing requirements. *Develops and maintains constructive relations with key internal and external colleagues, e.g. cross functional colleagues within the company
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
* BS, advanced scientific degree preferred.
* A minimum of 7years of pharmaceutical industry experience. This is inclusive of 5 years of regulatory experience or combination of 10 years regulatory and/or related experience in the vaccine area. * Vaccines and/or biologics experience is preferred..
* Preferred experience in managing multiple filings 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.
* Exceptionally strong in the following areas: working well with others including on cross-functional teams and communication with leadership
Sthree US is acting as an Employment Business in relation to this vacancy.