- Serves as the Lead, Regulatory Affairs Vaccines, on a Global Project Team; a proven decision-maker based on a strong knowledge of regulatory affairs for vaccines.
- Provides regulatory oversight for multiple projects covering a minimum of one highly active therapy area, focused on non-clinical, clinical and CMC aspects of drug development and associated regulations.
- Provides leadership and training for direct reports including those responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts.
- Collaborates with all Takeda regional and CMC counterparts to ensure a global regulatory strategy is created and executed upon for all projects within therapeutic area of responsibility.
- Has a passion for quality in all areas of responsibility.
- Authors and ensures global regulatory strategies are developed and accurately reflected in the RFP (Regulatory Functional Plan). Works closely with RAV Regional Regulatory Heads and the Global Head of CMC RAV to develop global strategy.
- Oversees and accountable for all Health Authority submissions and approvals within area of responsibility. Has a quality focus so that submissions are right-first-time.
- Oversees and accountable for ensuring dossiers are submitted on schedule by local Takeda affiliates, as applicable, within area of responsibility by ensuring the regulatory deliverables are provided as outlined in the RFP.
- In collaboration with RAV Regional Regulatory Heads and /or the Global Head of RAV CMC, works to resolve regional critical conflicts in global regulatory strategies and oversee critical deliverables to all territories as agreed within the global regulatory strategy.
- Supervises direct reports, as assigned. Manages, trains and provides oversight for staff day-to-day activities.
- Leads and manages Health Authority meetings, as applicable.
- Lead regulatory reviewer in due diligence for licensing opportunities, as assigned.
- Manages resources (internal or external) to meet program demands. Elevates needs when necessary.
- Identifies regulatory requirements and trends across therapeutic area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas.
- Uses excellent judgment when making decisions; escalates issues / decisions as appropriate.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- BS required, advanced scientific degree preferred.
- A minimum of 10 years of pharmaceutical industry experience required. This is inclusive of 8 years of regulatory experience or combination of 10 years regulatory and/or related experience in the vaccine area.
- Preferred experience in managing multiple filings resulting in first-time approval; or managing multiple programs in closely related development area; global experience necessary.
- Preferred experience in managing personnel
- Understands and interprets complex scientific issues across projects and therapy 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 global teams, global-mindset, and communication with senior leadership.
- Must be a strong leader that creates a regulatory vision for the GPT. Inspires and motivates. Takes stand on important issues in productive, respectful way.
- 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 or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 30 % travel.
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