- 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 regulatory lead on the global clinical development team (GCDT) 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 projects of responsibility.
- Primary regulatory authority contact for projects of responsibility or can delegate to staff with oversight.
Qualifications EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Working with global colleagues (if applicable), leads the regulatory working team and represents team at GCDT ensures global regulatory strategy written and executed according to plan - or oversees if delegated to staff.
- Accountable for all 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 achieveing major submissions.
- Accountable for ensuring all other regulatory submissions within outside of region 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.
- Oversee multiple projects and manager individual projects.
- For the project(s) of responsibility, collaborates with global colleagues and/or other regional counterparts in the authoring of global regulatory strategies and ensures critical deliverables to territories outside of region 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 regulatory authority interactions/meetings.
- Lead and manage Agency meetings.
- Lead regulatory reviewer in due diligence for licensing opportunities.
- Identifies and proposes solutions to the management of for any resource gaps for areas of 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.
- 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.
- 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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