- Defines, develops and leads global/regional strategies to maximize regulatory success towards achievement of program objectives. Effectively communicates objective assessments of the likelihood of success of these regulatory strategies. Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with regulatory requirements.
- Provides regulatory expertise for multiple projects within core therapeutic area, focused on non-clinical and clinical aspects of drug development, post marketing compliance and life cycle management.
- Provides leadership and development for multiple direct reports, potentially in various regions/sites, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts.
- Provides direction to senior leadership and teams on emerging trends, regulations and changes, with emphasis on those related to therapeutic areas of responsibility enabling proactive approach and planning to future business requirements
- Acts as deputy to the therapeutic area regulatory head, attending critical internal leadership team meetings, as appropriate. Provides regulatory guidance and participates in critical regulatory meetings with regulatory authorities. Determines Takeda impact and remediation requirements and provides interpretation and direction to the business
- Oversees global regulatory leads and staff responsible for ensuring regulatory strategies are written, reviewed and executed according to plan. Provide strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with regulatory requirements
- Collaborates with Takeda counterparts to ensure a global regulatory strategy is created and executed upon for all projects within therapeutic area of responsibility. Identifies regulatory requirements and trends across therapeutic area of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas.
- Directs and oversees multiple projects, generally has global/regional oversight for compounds in a minimum of one disease area.
- Oversees and accountable for working with other RA functions to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility as outlined in the global regulatory strategy.
- Works to resolve regional critical conflicts in global regulatory strategies and oversee critical deliverables as defined within the global regulatory strategy and plan. Approves global regulatory strategies and authors for more complex regulatory strategies as needed; over see execution, generally delegates to staff.
- Supervises multiple direct reports. Manages, trains and provides oversight for staff day-to-day activities.
- Leads critical interactions/meetings with senior representatives of appropriate health authorities; delegates to staff, as appropriate, for other health authority interactions Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to achieve Takeda strategic goals and objectives.
- Lead regulatory reviewer in due diligence for licensing opportunities.
- Presents to senior management.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- 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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