- Responsible for regulatory activities supporting the development of vaccine candidates in the US and Canada.
- Manages regulatory projects and submissions for 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 and associated regulations.
- Collaborates with all Takeda regulatory counterparts to ensure global regulatory alignment for all projects within area of responsibility.
- 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 FDA. 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.
- Acts 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 non-clinical and clinical aspects of drug development and associated regulations.
- Accountable for overall content and management of local regulatory components and filings i.e. NDA/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.
- Leads and manages health authority meetings as applicable for specified projects.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- BS degree, advanced scientific degree preferred.
- A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience in the vaccine area.
- Vaccines and/or biologics experience is strongly preferred.
- Preferred experience in managing filings resulting in first-time approval; or managing 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 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.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling.
- Willingness to travel to various meetings, including overnight trips. Some international travel may be required.
- Requires approximately 20 % travel.
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