- Plans/manage/executes all regulatory activities of all levels of complexity for project of responsibility in development and/or supports regulatory activities for assigned marketed product of responsibility.
- Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
- Serves as regulatory lead on the global development team (GDT) for individual project of responsibility. Can have multiple projects depending on development stage and complexity.
- Collaborates with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within project of responsibility.
- Primary FDA contact for project of responsibility.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Working with EU co-lead (if applicable), leads the regulatory working team and represents team at GDT; ensures global regulatory strategy is written and executed according to plan.
- Accountable for all US FDA submissions and approvals for project(s) of responsibility.
- Accountable for ensuring all other regulatory submissions within the non-US "Americas" territories are submitted on schedule by local Takeda affiliates within project(s) of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy.
- For the project(s) of responsibility, collaborates with EU Regulatory affairs and other regional counterparts ensuring critical deliverables to territories are provided outside the Americas to ensure regional execution of the strategy as agreed within the global regulatory strategy
- Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
- Generally serves as regulatory lead on the global development team (GDT) for individual project(s) of responsibility. Collaborates with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within project(s) of responsibility.
- Generally the primary FDA contact for project(s) of responsibility.
- Executes day-to-day activities for projects.
- Assists and attend FDA meetings and can lead with oversight.
- Assists in the due diligence review of licensing opportunities.
- Identifies and notifies management of resource gaps for assigned project(s), when necessary.
- Ensure regulatory compliance of marketed products.
- BSc Degree, preferred. BA accepted.
- Minimum of 5 years of pharmaceutical industry experience. This is inclusive of 3 years of regulatory experience or combination of 5 years regulatory and/or related experience.
- Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
- Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects.
- Demonstrates acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Demonstrates acceptable skills with increasing independence 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.
- Must work well with others and within teams.
- Able to bring working teams together for common objectives.
- 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 20 % travel.
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