- Oversees as well as executed all regulatory activities of multiple projects including one highly complex project in development and/or supports regulatory activities for assigned marketed product(s) of responsibility.
- Manages director reports to support scope of project work.
- Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
- Serves as global regulatory lead (GRL) on the global project team (GPT) for individual project(s) of responsibility or delegates to staff with oversight
- Collaborates with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility.
- Primary FDA contact for projects of responsibility or can delegate to staff with oversight.
- Leads the global regulatory subteam (GRT) and represents team at GPT ensures global regulatory strategy written and executed according to plan or oversees if delegated to staff.
- Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible.
- Responsible for independently achieving all submissions levels, including major submissions (NDA/BLA/MAA); may oversee staff in achieving major submissions.
- Accountable for ensuring all other regulatory submissions within the non-US Americas territories are submitted on schedule by local Takeda affiliates or development partners (eg, PRA or co-development partners) within project(s) of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy.
- Oversee multiple projects and manager individual projects.
- For the project(s) of responsibility, collaborates with EU and/or other regional counterparts in the authoring of global regulatory strategies and ensures critical deliverables to territories outside the US to ensure regional execution of the strategy as agreed within the global regulatory strategy
- Develop/author and execute global regulatory strategies for more complex strategies. May oversee execution.
- Executes day-to-day activities for projects or delegates to staff with oversight.
- Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
- Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings.
- Lead and manage Agency meetings.
- Lead regulatory reviewer in due diligence for licensing opportunities.
- Identifies and proposes solutions to management for any resource gaps for project responsibility.
- Provides oversight to ensure regulatory compliance of marketed products.
- Present to senior management as requested.
- Usually includes supervision of one or more direct reports.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BSc Degree preferred. BA accepted.
- Advanced 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.
- Solid working knowledge of drug development process and regulatory requirements, knowledge of FDA, EU, Canada, ROW, and post-marketing a plus.
- Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies
- Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
- Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership
- Generally strong and independent skills 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.
- Generally strong leader who is effective manager and is able to bring working teams together for common objectives, people management experience preferred.
- 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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